Staff Manufacturing Engineer

🏢 Summary: The Manager, Quality Systems leads and continuously improves the Quality Management System for a medical device company, ensuring compliance with FDA, ISO 13485, EU MDR, CHAP, and DME requirements. The role oversees document control, CAPA, nonconformance, audits, training, and regulatory activities while serving as deputy management representative during inspections. This position drives audit readiness, regulatory compliance, and cross-functional quality initiatives in a regulated manufacturing environment. 🗂️ Requirements: 5+ years Quality Assurance experience in medical device industry, 2+ years people management experience, Knowledge of ISO 13485, Knowledge of 21 CFR Part 820, Knowledge of FDA Quality System Regulations, Knowledge of EU MDR requirements, Experience in regulated manufacturing environments, Experience with eQMS systems, Experience with PLM systems, Experience managing CAPA and nonconformance processes, Experience conducting internal and external audits, Experience working with regulatory agencies (FDA, BSI, CHAP), Ability to manage DME compliance requirements 📃 Skills: ISO13485, 21CFR820, FDA, EUMDR, eQMS, PLM, CAPA, Audit, Nonconformance, DME, CHAP, BSI 🏢 Description: Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. SUMMARY OF ROLE: The Manager, Quality Systems is responsible for day-to-day operation and continuous improvement of the Quality System. The role is responsible for Document Control, Training Program, Change Control, Internal & External Audit Program, Management Review, Nonconformance management and CAPA management. The Manager, Quality Systems serves as deputy management representative representing the organization in internal and external audits. This role serves as co-system administrator for eQMS and works with cross functional stakeholders ensuring the organization continues to maintain CHAP accreditation and compliance with DME requirements including managing external DME audits, maintaining quality documentation and ensuring adherence to regulatory standards. This role supports EU MDR deliverables in collaboration with external regulatory consultants. This role plays a key part in sustaining a compliant, audit-ready QMS that upholds patient safety and organizational integrity. RESPONSIBILITIES: - Lead, mentor, and develop Quality Systems team members, fostering a culture of quality, accountability, collaboration, and continuous improvement - Partner cross-functionally to investigate quality issues, interpret data trends, and drive timely, risk-based decisions - Build and maintain strong working relationships with internal stakeholders, external auditors, and regulatory partners - Own and maintain the Document Control system, ensuring controlled documents remain accurate, current, compliant, and properly version-controlled - Administer and continuously enhance the company training program, ensuring timely completion, training effectiveness, and maintenance of compliant training records - Own the CAPA program, including driving timely resolution of aging CAPAs, ensuring robust root cause investigations, and monitoring closure effectiveness and metrics - Manage Nonconformance (NC) processes from initiation through final disposition and closure, ensuring timely and compliant execution - Lead Management Review activities, including development of quality metrics, trend analysis, and executive-ready Quality Management Review (QMR) materials - Monitor, analyze, and trend quality system metrics to proactively identify systemic risks, drive corrective actions, and support continuous improvement initiatives - Support post-market surveillance activities, including maintenance of associated documentation and reporting requirements - Support EU MDR compliance activities in partnership with external regulatory consultants, including CERs, PSURs, and PMS deliverables - Maintain quality documentation and records necessary to support BSI certification activities and ongoing CE mark compliance - Own and execute the Internal Audit Program, including audit planning, scheduling, execution, findings management, and verification of corrective action closure - Coordinate CHAP accreditation activities and ongoing DME compliance requirements, including preparation for and management of external audits - Partner with external auditors and regulatory agencies to support inspections, audits, and compliance readiness activities - Ensure the Quality Management System remains compliant with FDA, ISO 13485, CHAP, EU MDR, and other applicable regulatory and quality standards - Support system validation activities, process improvements, and ongoing enhancements to quality systems and tools as needed QUALIFICATIONS: - 5+ years of progressive Quality Assurance experience within the medical device industry, including experience in regulated manufacturing environments - 2+ years of people leadership or management experience, with demonstrated ability to lead and develop high-performing teams - Strong working knowledge of ISO 13485, 21 CFR Part 820, FDA Quality System Regulations, and EU MDR requirements - Hands-on experience utilizing eQMS and PLM systems to support quality and compliance initiatives - Ability to interpret, implement, and adapt to evolving regulatory requirements, including DME quality system standards - Solid understanding of core quality processes, including CAPA, nonconformance management, complaint handling, change control, and internal auditing - Experience partnering with external auditors and regulatory agencies, including BSI, FDA, CHAP, or equivalent organizations - Demonstrated ability to manage multiple priorities and drive execution in a fast-paced, evolving environment - Strong analytical and problem-solving skills, with the ability to identify trends, summarize findings, and communicate recommendations to leadership BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to: - Stock Options - 90% employer-paid medical, dental, and vision insurance - Company-paid Basic Life Insurance - 401(k) retirement plan (Traditional and Roth) - Competitive Paid Time Off - Paid Holidays - FSA (Flexible Spending Accounts) - HSA (Health Savings Account) - Employee Assistance Program through PEO The salary for this exempt-level position will be based on experience and qualifications within an established pay range. Pay range: $144,000 - $154,000 Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on non-merit-based factors prohibited by law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management within the DME/HME space. The position owns claims submission, AR follow-up, denials and appeals, and payment posting while helping build scalable billing processes during early commercialization. This role combines hands-on reimbursement operations with system optimization and cross-functional collaboration. 🗂️ Requirements: 3–5+ years medical billing and RCM experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Understanding of HCPCS and ICD-10 coding, Experience with CMNs and Prior Authorizations, Ability to manage full-cycle insurance claims and AR follow-up, Proficiency in billing systems (Niko Health or BrightTree preferred), Experience with CRM systems and payer portals (e.g., Availity) 📃 Skills: RCM, DME, HME, HCPCS, ICD-10, CMN, PriorAuthorizations, Medicare, Medicaid, Availity, NikoHealth, BrightTree, CRM 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role, it's an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we're looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you'll own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You'll work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management - Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). - AR Follow-up: Monitor and aggressively pursue unpaid claims. - Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. - Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy - Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. - Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. - Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight - SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. - Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. - System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: - Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. - Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. - Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. - The "Startup" Mindset: You are comfortable with ambiguity. You don't just wait for a manual; you help write it. - Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. - Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity. BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to: - Stock Options - 90% employer-paid medical, dental, and vision insurance - Company-paid Basic Life Insurance - 401(k) retirement plan (Traditional and Roth) - Competitive Paid Time Off - Paid Holidays - FSA (Flexible Spending Accounts) - HSA (Health Savings Account) - Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on full-cycle medical billing and revenue cycle management within the DME/HME industry. The position owns claims submission, AR follow-up, denials and appeals, payment posting, and patient billing support while helping build scalable billing processes. Ideal for an experienced medical billing professional who thrives in a fast-growing environment and can optimize reimbursement operations. 🗂️ Requirements: 3–5+ years medical billing and Revenue Cycle Management experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Strong understanding of HCPCS codes, Strong understanding of ICD-10 coding, Experience with CMNs and Prior Authorizations, Experience with electronic and paper claims submission, Ability to manage denials and appeals, Proficiency in billing systems, Proficiency in CRM systems, Experience with payer portals (e.g., Availity) 📃 Skills: HCPCS, ICD-10, CMN, PriorAuthorization, Medicare, Medicaid, DME, HME, NikoHealth, BrightTree, CRM, Availity, ERAs, EOBs 🏢 Description: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. SUMMARY OF ROLE: This is more than a billing role, it's an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we're looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you'll own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You'll work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The "Startup" Mindset: You are comfortable with ambiguity. You don't just wait for a manual; you help write it. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management within the DME sector. The position involves owning claims submission, AR follow-up, denials and appeals, patient billing support, and helping build scalable billing processes in a growing commercialization-stage environment. This role combines hands-on reimbursement operations with system optimization and SOP development to support efficient, compliant revenue workflows. 🗂️ Requirements: 3–5+ years of medical billing and Revenue Cycle Management experience, Experience within Durable Medical Equipment (DME) or HME industry, Knowledge of monthly rental billing and capped rental workflows, Strong understanding of HCPCS codes and ICD-10 coding, Experience with CMNs and Prior Authorizations, Experience submitting electronic and paper claims to Medicare, Medicaid, and private payers, Ability to manage denials, appeals, and AR follow-up, Proficiency in billing systems and payer portals, Eligibility to work in the United States without visa sponsorship 📃 Skills: RCM, DME, HCPCS, ICD-10, CMN, PriorAuthorization, Medicare, Medicaid, Niko, BrightTree, CRM, Availity, ERAs, EOBs 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role; it is an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we are looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you will own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You will work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The "Startup" Mindset: You are comfortable with ambiguity and help build processes where none exist. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and payer portals such as Availity. BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, relocation assistance is not offered.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management for a cardiac medical device company. The position owns claims submission, AR follow-up, denials and appeals, payment posting, and patient billing while helping build scalable billing processes. Ideal for an experienced DME billing professional comfortable with payer regulations, coding standards, and billing systems in a high-growth environment. 🗂️ Requirements: 3–5+ years medical billing and RCM experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Understanding of HCPCS and ICD-10 coding, Experience with CMNs and prior authorizations, Ability to manage full-cycle insurance billing and AR, Proficiency in billing systems and payer portals, Eligibility to work in the United States 📃 Skills: HCPCS, ICD-10, CMN, RCM, DME, HME, Niko, BrightTree, CRM, Availity, Medicare, Medicaid 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role; it is an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we are looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you will own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You will work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce days in AR. QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The Startup Mindset: Comfortable with ambiguity and able to help build processes. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity. BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

🏢 Summary: Staff Manufacturing Engineer role focused on scaling a large rare-earth magnet manufacturing facility from equipment selection and commissioning through full production. The position involves process ownership, manufacturing optimization, heavy equipment integration, and collaboration with R&D to develop advanced production systems. Candidates will lead technical projects, ensure quality and safety compliance, and support production startup activities. 🗂️ Requirements: Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related field, 7+ years of manufacturing engineering experience or Master's degree with 5+ years of experience, Strong CAD experience with complex equipment assemblies, Experience in heavy custom equipment design and commissioning, Vendor management experience, Experience with thermal or raw material processing, Ability to create manufacturing documentation including PFMEA, Control Plans, Work Instructions, and Process Flows, Ability to read and create electrical schematics and pneumatic diagrams, Ability to perform electrical and pneumatic engineering calculations, U.S. Person status for export-controlled access 📃 Skills: CAD, PFMEA, BOP, BOM, OEE, HMI, MES, FAT, SOP, R&R, Simulation, Electrical, Pneumatic, Metallurgy, Foundry, Manufacturing 🏢 Description: About Vulcan Elements Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, and automotive powering a high-technology future. Vulcan Elements is building a team of ambitious professionals committed to Mission Focus, Technical Excellence, and Transparency. The Role As a Staff Manufacturing Engineer, you will contribute to the full lifecycle of a massive 1 million square foot manufacturing facility expansion—from design and equipment specification through installation, commissioning, production startup, and scale-up to full capacity. You will be responsible for a process step, translating pilot-line processes into full-scale, stable, and repeatable production systems. This is a high-impact, high-ownership role requiring deep technical expertise and leadership. Core Expectations & Responsibilities • Lead the evaluation, quote comparison, and selection of advanced manufacturing technologies and vendors. • Own equipment design requirements, vendor performance and schedule, commissioning activities, process development, and production qualification for major heavy production processes. • Develop and optimize manufacturing processes to improve throughput, quality, and equipment reliability. • Monitor OEE results and station cycle times to drive yield and capacity improvements. • Manage technical schedules, budgets, and deliverables aligned with company milestones and customer commitments. • Provide hands-on support during production startup to stabilize processes and eliminate bottlenecks. • Collaborate with R&D to develop innovative processes and equipment strategies for future production lines. • Ensure compliance with safety, environmental, and quality standards. • Support equipment development reviews and Factory Acceptance Tests (FATs) with occasional travel. Deliverables Risk & Safety • Risk Assessments • Ergonomic Assessments • PFMEA Process Design • Line Layouts • Process Flow Charts • Bill of Process (BOP) • Station Cycle Times • Process Sheets • Simulations Engineering Diagrams • CAD Drawings • Electrical Drawings • Pneumatic Drawings • Electrical and Pneumatic Calculations Quality & Control • Quality Control Plans • R&R Studies • Quality Checklists • Process Checklists Operations & Maintenance • Work Instructions (SOPs) • Calibration Procedures • Spare Parts Lists • Bill of Materials (BOM) • Maintenance Manuals Controls & IT • HMI Controls Manuals • Vision Programs • MES Transactions Lists Qualifications • Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related technical discipline with 7+ years of experience, or Master's degree with 5+ years of experience. • Strong hands-on CAD experience creating, modifying, and validating complex equipment assemblies. • Proven experience in heavy custom equipment design, vendor management, and full-cycle commissioning for thermal or raw material processing. • Expert-level experience developing PFMEA, Control Plans, Work Instructions, and Process Flows. • Ability to read, interpret, and create electrical schematics and pneumatic diagrams and perform engineering calculations. • Must be a U.S. Person due to required access to U.S. export-controlled information or facilities. Preferred Qualifications • Experience in heavy industrial manufacturing, metallurgy, foundry operations, or chemical processing. • Experience handling reactive powders or high-temperature vacuum furnace environments. • Proficiency with advanced simulation software for workflow and line balancing. • Familiarity with MES implementation and transaction mapping.

🏢 Summary: Staff Manufacturing Engineer role focused on scaling advanced rare-earth magnet manufacturing from pilot line to full-scale production, including equipment selection, process optimization, commissioning, and production startup. The position involves ownership of heavy industrial manufacturing processes, technical project management, and development of engineering, quality, and operational documentation. Candidates will support process innovation, compliance, and collaboration with vendors and R&D teams in a high-growth manufacturing environment. 🗂️ Requirements: Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related technical field, 7+ years of relevant experience or Master's degree with 5+ years of experience, Hands-on CAD experience with complex equipment assemblies, Experience in heavy custom equipment design and commissioning, Vendor management experience, Experience with thermal or raw material processing systems, Expertise creating PFMEA, Control Plans, Work Instructions, and Process Flows, Ability to read and create electrical schematics and pneumatic diagrams, Ability to perform electrical and pneumatic calculations, U.S. Person status for access to export-controlled information 📃 Skills: CAD, PFMEA, BOP, BOM, MES, HMI, OEE, FAT, SOPs, Simulation, Electrical, Pneumatic, Commissioning, Metallurgy, Foundry 🏢 Description: About Vulcan Elements Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, the company serves critical industries such as defense, aerospace, and automotive, powering a high-technology future. The Role As a Staff Manufacturing Engineer, you will contribute to the full lifecycle of a massive 1 million square foot manufacturing facility expansion—from design and equipment specification through installation, commissioning, production startup, and scale-up to full capacity. You will be responsible for a process step, translating pilot-line processes into full-scale, stable, and repeatable production systems. This is a high-impact, high-ownership role requiring deep technical expertise and leadership. Core Expectations & Responsibilities • Lead the evaluation, quote comparison, and selection of advanced manufacturing technologies and vendors. • Own equipment design requirements, vendor performance and schedule, commissioning activities, process development, and production qualification for major heavy production processes including alloy production, casting, jet milling, powder production, pressing, and sintering operations. • Develop and optimize manufacturing processes to improve throughput, quality, and equipment reliability. • Monitor OEE results and station cycle times to drive yield and capacity improvements. • Manage technical schedules, budgets, and deliverables aligned with company milestones and customer commitments. • Provide hands-on support during production startup to stabilize processes and eliminate bottlenecks. • Collaborate with R&D to innovate new processes and equipment strategies for future production lines. • Ensure compliance with safety, environmental, and quality standards. • Support equipment development reviews and Factory Acceptance Tests (FATs) with up to 25% travel. Deliverables Risk & Safety: • Risk Assessments • Ergonomic Assessments • PFMEA Process Design: • Line Layouts • Process Flow Charts • Bill of Process (BOP) • Station Cycle Times • Process Sheets • Simulations Engineering Diagrams: • CAD Drawings • Electrical Drawings • Pneumatic Drawings • Electrical and Pneumatic Calculations Quality & Control: • Quality Control Plans • R&R Studies • Quality Checklists • Process Checklists Operations & Maintenance: • Work Instructions (SOPs) • Calibration Procedures • Spare Parts Lists • Bill of Materials (BOM) • Maintenance Manuals Controls & IT: • HMI Controls Manuals • Vision Programs • MES Transactions Lists Qualifications • Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related technical discipline with 7+ years of experience, or Master's degree with 5+ years of experience. • Strong hands-on experience creating, modifying, and validating complex equipment assemblies in CAD. • Proven experience in heavy custom equipment design, vendor management, and full-cycle commissioning for thermal or raw material processing. • Expert-level experience authoring PFMEA, Control Plans, Work Instructions, and Process Flows. • Ability to read, interpret, and create electrical schematics and pneumatic diagrams, including performing engineering calculations. • Must be a U.S. Person due to required access to export-controlled information or facilities. Preferred Qualifications • Experience in heavy industrial manufacturing, metallurgy, foundry operations, or chemical processing. • Experience handling reactive powders or high-temperature vacuum furnace environments. • Proficiency with advanced simulation software for workflow and line balancing. • Familiarity with MES implementation and transaction mapping.

🏢 Summary: Staff Manufacturing Engineer role focused on scaling a large rare-earth magnet manufacturing facility from design through production startup and optimization. The position owns manufacturing processes, equipment selection, commissioning, process optimization, and quality compliance in a heavy industrial environment. The role requires strong expertise in CAD, process engineering, equipment commissioning, and manufacturing documentation. 🗂️ Requirements: Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related discipline, 7+ years of experience with Bachelor's degree or 5+ years with Master's degree, Hands-on CAD experience with complex equipment assemblies, Experience in heavy custom equipment design and commissioning, Vendor management experience, Experience with thermal or raw material processing, Expert knowledge of PFMEA, Control Plans, Work Instructions, and Process Flows, Ability to read and create electrical schematics and pneumatic diagrams, Ability to perform electrical and pneumatic engineering calculations, U.S. Person status for export-controlled access 📃 Skills: CAD, PFMEA, BOP, BOM, MES, HMI, OEE, FAT, SOPs, Simulation, Pneumatics, Electrical, Commissioning, Metallurgy, Manufacturing 🏢 Description: About Vulcan Elements Vulcan Elements is manufacturing American rare-earth permanent magnets for a secure, resilient future. With a focus on national security and economic resiliency, we serve critical industries such as defense, aerospace, and automotive powering a high-technology future. Vulcan Elements is building a team of ambitious professionals committed to Mission Focus, Technical Excellence, and Transparency. The Role As a Staff Manufacturing Engineer, you will contribute to the full lifecycle of a massive 1 million square foot manufacturing facility expansion—from design and equipment specification through installation, commissioning, production startup, and scale-up to full capacity. You will be responsible for a process step, translating pilot-line processes into full-scale, stable, and repeatable production systems. This is a high-impact, high-ownership role requiring deep technical expertise and leadership. Core Expectations & Responsibilities Critical Priority — Equipment & Vendor Selection: - Lead the evaluation, quote comparison, and selection of advanced manufacturing technologies and vendors. - Own the technical and financial side-by-side comparisons to ensure selected machinery meets aggressive scaling and quality goals. End-to-End Process Ownership: - Own equipment design/requirements, vendor performance and schedule, commissioning activities, process development, and production qualification for a major heavy production process. - Support processes including alloy production, casting, jet milling, powder production, pressing, and sintering operations. Process Optimization: - Develop and optimize manufacturing processes to improve throughput, quality, and equipment reliability. - Monitor OEE results and station cycle times to drive yield and capacity improvements. Project Management: - Manage technical schedules, budgets, and deliverables aligned with company milestones and customer commitments. Hands-on Startup Support: - Provide hands-on support during production startup, helping stabilize processes and eliminate early bottlenecks. Future Innovation: - Develop and innovate new processes and equipment strategies in collaboration with R&D for future production lines. EHS & Quality Compliance: - Ensure compliance with safety, environmental, and quality standards across all process activities. Travel: - Some travel required to support equipment development reviews and Factory Acceptance Tests (estimated at less than 25%). Deliverables Risk & Safety: - Risk Assessments - Ergonomic Assessments - PFMEA Process Design: - Line Layouts - Process Flow Charts - Bill of Process (BOP) - Station Cycle Times - Process Sheets - Simulations Engineering Diagrams: - CAD Drawings - Electrical Drawings - Pneumatic Drawings - Electrical and Pneumatic Calculations Quality & Control: - Quality Control Plans - R&R Studies - Quality Checklists - Process Checklists Operations & Maintenance: - Work Instructions (SOPs) - Calibration Procedures - Spare Parts Lists - Bill of Materials (BOM) - Maintenance Manuals Controls & IT: - HMI Controls Manuals - Vision Programs - MES Transactions Lists Responsibilities and tasks outlined are not exhaustive and may change as determined by business needs. Qualifications Education & Experience: - Bachelor's degree in Mechanical Engineering, Materials Science, Metallurgical Engineering, or related technical discipline with 7+ years of experience, or a Master's degree with 5+ years of experience. CAD Proficiency: - Strong hands-on experience creating, modifying, and validating complex equipment assemblies in CAD. Equipment Design & Commissioning: - Proven track record in heavy custom equipment design, vendor management, and full-cycle commissioning for thermal or raw material processing. Documentation Mastery: - Expert-level experience authoring and developing PFMEA, Control Plans, Work Instructions, and Process Flows. Technical Literacy: - Ability to read, interpret, and create electrical schematics and pneumatic diagrams, including performing electrical and pneumatic calculations. - Must be a U.S. Person due to required access to U.S. export-controlled information or facilities. Preferred Qualifications - Experience in heavy industrial manufacturing, metallurgy, foundry operations, or chemical processing. - Experience handling reactive powders or managing high-temperature vacuum furnace environments. - Proficiency with advanced simulation software for workflow and line balancing. - Familiarity with MES implementation and transaction mapping.

🏢 Summary: Senior Mechanical Engineer role focused on designing, building, and optimizing high-volume capital equipment and high-vacuum manufacturing systems in a fast-paced semiconductor and advanced manufacturing environment. The position involves cross-disciplinary engineering collaboration, supplier management, automation integration, and facilities system design. 🗂️ Requirements: Bachelor's or Master's degree in Mechanical Engineering or related field, 15+ years of engineering design experience in high-volume manufacturing tools, Experience with 2D and 3D CAD, Proficiency in AutoCAD, Proficiency in SolidWorks, Experience with PDM or PLM systems, Experience with welded steel frames and sheet metal design, Experience with machined parts and process piping design, Experience with electrical and pipe routing design, Knowledge of high purity, caustic, and explosive gas systems, Experience with high pressure and high vacuum piping systems, Knowledge of welding methods and safety considerations, Experience with mechanical automation and robotics, Experience with precision alignment of large tools, Strong analytical and problem-solving skills, Ability to work in a fast-paced collaborative environment, Effective communication skills 📃 Skills: AutoCAD, SolidWorks, CAD, PDM, PLM, Robotics, Automation, Welding, Piping, Vacuum, Manufacturing 🏢 Description: Diamond Foundry Inc. is solving the thermal limitation at the foundation of today's most exciting tech industries -- AI & cloud compute, electric-car power electronics, and 5G/6G wireless. We have managed to produce the world's first single-crystal diamond wafers and are now on a mission to put a diamond behind every chip. We’re looking for an ambitious Mechanical Engineer to take responsibility for designing capital equipment and facilities systems, working across multiple engineering disciplines. You'll be working with an experienced team of mechanical and electrical engineers to take a pragmatic approach to equipment and facility design. You’ll be responsible for whole projects, pulling in the talents of others when needed. This position will work out of our South San Francisco location. Responsibilities - Designing, building, testing, and optimizing systems for high-volume capital equipment and high vacuum manufacturing equipment. - Prototyping and integration of new system functions to enhance existing equipment - Managing multiple domestic and international suppliers to construct parts and assemblies on time and within budget - Effective communication skills and ability to convey complex technical concepts to diverse stakeholders Requirements - Bachelor's or Master's degree in Mechanical Engineering or a related field with 15+ years of applicable engineering design experience for high-volume, low-cost manufacturing tools. - Experience in 2D and 3D CAD (specifically AutoCAD and SolidWorks), proficiency in PDM and/or PLM software and systems, experience with welded steel frames, sheet metal, machined parts, process piping design and related connections, and documentation for high-volume builds. - Experience with electrical and pipe routing design such as high purity gases, caustic and explosive gases, manual and automatic valves, and experience with their appropriate use. - Experience with commercially available piping connection systems for high pressure and high vacuum, welding methods, and applicable safety considerations for these systems. - Experience with mechanical automation, repetitive moving systems, material flow, robotics, precision alignment of large tools, and facilities design. - Strong analytical skills to investigate and provide solutions for problems across multiple systems within a facility - Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment Benefits Diamond Foundry believes in supporting employees from the workplace to their personal and home life. Benefits generally include health insurance, flexible spending accounts, retirement savings plans, life and disability insurance programs, paid and unpaid time away from work, and employee discounts. Benefits begin as early as the first day of employment. Manufacturing and Engineering Departments Physical Requirements - Use appropriate PPE and follow all safety policies, practices, and procedures. - Sit, stand for long periods, walk, grasp, reach with hands and arms, lift below and above shoulders, bend, twist at the waist, climb, balance, stoop, squat, kneel, crawl, talk, hear, see, use fine finger manipulation, and complete repetitive motions. - Some tasks may require the use of ladders or stairs - Some tasks may require driving or the use of foot controls - Lift/carry and push/pull up to 50 pounds This employer participates in E-Verify and will provide the federal government with Form I-9 information to confirm authorization to work in the U.S.

🏢 Summary: The role leads enterprise engineering strategy for a regulated healthcare platform, overseeing cloud-native systems, mobile products, data architecture, and AI initiatives. It focuses on building scalable, compliant digital solutions that support manufacturing, patient engagement, and prescribing workflows in highly regulated environments. The position also drives AI adoption, operational excellence, and high-performance engineering team leadership. 🗂️ Requirements: Expertise in cloud-native architecture, Experience with mobile platforms, Knowledge of data engineering, Experience deploying AI systems in regulated environments, Understanding of FDA, GxP, DEA, HIPAA, and data governance requirements, Ability to operationalize explainable AI and model governance, Product leadership experience for digital healthcare platforms, Executive-level communication skills, Experience managing technology risk and compliance, Ability to build and scale engineering organizations 📃 Skills: Cloud, Mobile, AI, Data, HIPAA, FDA, GxP, DEA, Analytics, Architecture, Governance, Compliance 🏢 Description: Position Summary: The Director, Engineering is responsible for architecting and scaling a regulated digital ecosystem to support hyper-growth, patient safety, and enterprise velocity. This role owns the digital backbone spanning cloud platforms, mobile products, data, and AI-enabled systems that power manufacturing, quality, patient engagement, and prescribing experiences. Operating at the intersection of technology, regulation, and strategy, the Director translates enterprise priorities into scalable digital platforms that withstand regulatory scrutiny while enabling rapid innovation. Success requires embedding compliance, auditability, and intelligence directly into system design, ensuring digital capabilities compound value over time. This leader defines and executes AI strategy, deploying production-grade, explainable AI in high-stakes environments to automate complexity, improve decision velocity, and elevate outcomes. The role also builds and leads a high-performance digital organization from the ground up, establishing operating rhythms, accountability, and talent density that enable durable execution at global scale. Responsibilities: Enterprise Digital Strategy and Architecture - Define and execute a multi-year digital strategy aligned to enterprise growth, regulatory demands, and AI-enabled scalability. - Architect cloud-native, modular platforms embedding compliance, auditability, and data integrity by design. - Partner with executives to evaluate tradeoffs using system behavior, regulatory risk, and long-term value creation. Product and Mobile Experience Leadership - Own digital product strategy across patient, prescriber, and internal platforms with outcome accountability. - Lead secure, high-performance mobile experiences that personalize care and streamline prescribing workflows. - Establish agile delivery models balancing rapid iteration, quality, and regulatory readiness. Artificial Intelligence and Data Enablement - Define enterprise AI strategy focused on high-impact, regulated use cases across operations and care delivery. - Deploy production-grade, explainable AI systems that perform reliably under regulatory scrutiny. - Build data architectures and analytics foundations enabling predictive insight and decision automation. Regulatory-Native Execution - Embed FDA, GxP, DEA, HIPAA, and data governance requirements into digital systems as core design constraints. - Ensure AI and digital platforms remain auditable, validated, and compliant throughout their lifecycle. - Actively manage technology risk, shutting down or redesigning initiatives that introduce unacceptable exposure. Organization and Operating Rhythm - Design and scale a high-performance digital organization aligned to enterprise priorities. - Attract, develop, and retain top-tier talent while maintaining high performance standards. - Establish operating cadences, metrics, and accountability mechanisms that translate commitments into results. Knowledge and Skills: - Deep expertise in cloud-native architecture, mobile platforms, data engineering, and AI systems deployed in regulated environments with high availability, security, and auditability requirements. - Proven ability to operationalize AI responsibly, including model governance, explainability, bias mitigation, and lifecycle management in high-stakes, compliance-driven settings. - Strong product leadership translating complex clinical, manufacturing, and operational workflows into intuitive, outcome-driven digital experiences. - Executive-level communication and systems thinking, enabling clear tradeoffs, cross-functional alignment, and disciplined execution at enterprise scale. Key Competencies: - Customer Focus: Builds trust through customer-centric solutions. - Strategic AI: Guides responsible AI adoption and adaptation. - Optimizes Work Processes: Drives efficiency with continuous improvement. - Collaborates: Partners effectively to achieve shared goals. - Resourcefulness: Secures and deploys resources efficiently. - Manages Complexity: Simplifies and solves complex challenges. - Ensures Accountability: Delivers on commitments with integrity. - Situational Adaptability: Adjusts approach to shifting conditions. - Communicates Effectively: Tailors messages to diverse audiences. Values: - People: Empowering people defines who we are. - Quality: Excellence in every product, every time. - Service: Serving others is our highest purpose. - Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Physical Requirements: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.