July 3, 2026
Risk Management (Medical Devices)
Senior • On-site
Indianapolis, IN
Position Summary
We are seeking a Risk Management Subject Matter Expert (SME) with extensive experience in medical device risk management and a solid background in Systems Engineering.
The consultant will support the development, review, and technical assessment of key risk management deliverables for the medical device program.
Key Responsibilities
Development and Review of Key Risk Management Deliverables
- Conduct the technical review of the PHA.
- Support the development and technical review of the BE CT CHA and platform CHA, including associated platform risk libraries.
- Ensure alignment with Systems Engineering deliverables (e.g., consistency between RCMs and design inputs).
- Verify alignment of risks and RCMs with applicable standards (e.g., ISO 11608, IEC 60601‑1, etc.).
- Support integration activities related to platform risk libraries.
Support for Additional Risk Management Deliverables
- Contribute to the development and review of the Platform Risk Management Plan (RMP).
- Participate in Functional Failure Analysis, including:
- Identification of system-level effects.
- Assignment of appropriate defect classifications.
- Support additional Risk Management deliverables as required throughout the project lifecycle.
- Review and structure existing FMEAs currently in Excel.
- Reformat data so it can be integrated into Turbo AC.
- Support the upcoming import process and ensure everything is properly structured.
- Assist with manual linking between hazards and FMEAs once uploaded.
Required Qualifications / Technical Competencies
- 8+ years of experience in Risk Management for medical devices.
- Strong background in Systems Engineering methodologies.
- Expertise with key standards, including ISO 14971, ISO 11608, and IEC 60601‑1 and related standards.
- Experience with TurboAC or risk management platforms is a strong plus.
Professional Skills
- Ability to conduct detailed and complex technical analyses.
- Excellent technical documentation and writing capabilities.
- High attention to detail and strong analytical mindset.
- Ability to collaborate effectively with cross-functional teams, including Systems Engineering, Quality, Design, and Platform Engineering.
Assignment Conditions
- On-site presence required in Indianapolis.
- Only candidates who are U.S. Citizens or U.S. Permanent Residents (Green Card holders) are eligible for consideration for this position.
- All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.
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Wroclaw, Poland
12,000 - 15,000 PLN
🏢 Summary: The offer is for a Quality Systems Specialist role focused on developing and maintaining a Healthcare Quality Management System for medical software products classified as Software as a Medical Device. The position involves ensuring regulatory compliance for EU and US markets, supporting audits, documentation, and quality processes across the full software lifecycle. The role emphasizes continuous improvement and alignment with medical device standards. 🗂️ Requirements: Minimum 3 years experience with medical device quality systems, Practical experience with ISO 13485, Practical experience with ISO 14971, Degree in engineering, medical technology, life sciences or related field, Experience with structured documentation in regulated environments, Ability to coordinate with multiple stakeholders, Strong analytical and documentation skills, Professional proficiency in English 📃 Skills: ISO13485, ISO14971, IEC62304, Agile, QMS, Audit, RegulatoryCompliance, Documentation, Validation 🏢 Description: Project overview You will be involved in the development and maintenance of a Healthcare Quality Management System that supports multiple medical software products delivered to international markets. The project focuses on aligning software engineering practices with medical device regulations and quality standards. Position overview We are looking for a Quality Systems Specialist who will contribute to building and maintaining quality systems for medical software products classified as Software as a Medical Device. You will work on regulatory compliant digital health solutions intended for the EU and US markets, focusing on quality processes, documentation, audits, and continuous improvement across the full software lifecycle. Responsibilities Maintain and support the Healthcare Quality Management System and its ongoing certification activities. Support preparation for and participation in external audits, including evidence collection and audit coordination. Provide quality support to medical software projects throughout planning, development, release, and maintenance phases. Prepare and execute internal audits, including audit planning, documentation, reporting, and follow up actions. Support coordination and tracking of corrective and preventive actions. Collaborate with engineering, legal, compliance, and other internal teams on quality and regulatory topics. Participate in customer audits and supplier evaluations within the scope of assigned projects. Contribute to continuous improvement initiatives and systemic quality enhancements. Support validation activities for quality management and documentation tools. Promote quality awareness by delivering internal workshops and training sessions. Requirements At least three years of experience working with medical device quality systems. Practical experience with ISO 13485 and ISO 14971. A degree in engineering, medical technology, life sciences, or a comparable field. Experience working with structured documentation and regulated processes. Ability to work independently while coordinating effectively with multiple stakeholders. Strong analytical, documentation, and written communication skills. Professional working proficiency in English. Interest in developing skills in regulatory affairs for medical software. Nice to have Experience participating in or conducting audits. Exposure to IEC 62304 or other medical software lifecycle standards. Understanding of Agile software development practices. Initial experience with EU or US medical device regulatory frameworks. What We Offer: Vacation days : Up to 26 business days per year. 10 illness/special days off per year (fully paid, no medical papers needed) for all contract types Health and life insurance (Luxmed) MyBenefit platform with Multisport option Internal psychological support service English language classes from the first working day Access to external learning platforms : O’Reilly, LinkedIn Learning, Udemy, and a wide catalog of diverse internal training Flexible workplace : work from the office, from home, or choose a hybrid option Tech Skills Mentoring Program Opportunities to develop as a public speaker, mentor, or technical interviewer Fully paid idle (bench) when not involved in a project Certification reimbursement (AWS, GCP, Microsoft, etc.)
Technology

i360technologies
Supply Systems Specialist | SME Management Analyst
Senior
On-site
Baltimore, MD
🏢 Summary: Seeking a Supply Systems Specialist / SME Management Analyst to support federal logistics and supply operations with expertise in NESSS, sector allowancing, and logistics data analysis. The role focuses on inventory management, supply system modernization, allowance validation, and resolving complex logistics issues in a federal client environment. 🗂️ Requirements: NESSS/Sector Allowancing expertise, Experience with federal logistics and supply management, Advanced proficiency with NESSS, Experience with allowance development or maintenance, Ability to interpret inventory management codes and configuration data, Knowledge of supply and logistics management policies and procedures, Experience reviewing SAS allowance reports, Ability to analyze logistics data and provide recommendations, Strong problem-solving skills, Strong written and verbal communication skills, Ability to work independently, Ability to obtain Public Trust clearance, U.S. Citizenship or Permanent Residency 📃 Skills: NESSS, SAS, Logistics, Supply, Allowancing, Inventory, Configuration, Analysis, Compliance, Documentation 🏢 Description: We are seeking a Supply Systems Specialist / SME Management Analyst to support a federal client, Business Operations Division (BOD). The specialist will provide subject matter expertise in the federal client's logistics data, supply management, NESSS, Sector Allowancing, and logistics modernization support. The ideal candidate will have hands-on experience supporting federal client supply operations, interpreting logistics data elements, validating material demand, and helping supply and logistics personnel resolve complex supply system issues. This position requires a strong working knowledge of the federal client's supply policies, logistics management procedures, configuration data, item management codes, and allowance development within the Naval and Electronics Supply Support System (NESSS). Key Responsibilities - Review, interpret, and analyze inventory item management codes within NESSS. - Analyze configuration data, item usage, and material demand to support operational readiness. - Develop, review, update, and validate Sector allowance levels for material within NESSS. - Assess and recommend changes to Sector allowances based on operational requirements, usage data, and supply analysis. - Identify terminal, obsolete, excess, or unsupported material and recommend appropriate disposal or disposition actions. - Request, review, and interpret SAS allowance reports to support allowance decisions and continuous process improvement. - Collaborate with Asset Logistics Division personnel and other stakeholders to resolve logistics and supply issues. - Provide expert guidance, training, and user support on NESSS usage, logistics data management, and supply best practices. - Support data system modernization efforts by providing subject matter expertise on supply and finance system requirements. - Help ensure supply data accuracy, policy compliance, and alignment with logistics standards. - Document findings, recommendations, process updates, and issue resolution actions in clear, professional formats. Qualifications - NESSS/Sector Allowancing expertise - Demonstrated experience with logistics, supply management, or asset logistics support - Advanced user-level proficiency with the Naval and Electronics Supply Support System (NESSS) - Experience with Sector Allowancing processes and allowance development or maintenance - Ability to interpret inventory item management codes, configuration data, supply records, and material demand data - Knowledge of supply and logistics management policies, procedures, and terminology - Experience reviewing or interpreting SAS allowance reports - Ability to analyze logistics data and provide practical recommendations to improve readiness, data quality, and supply support - Strong problem-solving skills and ability to resolve complex logistics or supply challenges - Strong written and verbal communication skills, including the ability to brief findings and provide guidance to stakeholders - Ability to work independently with minimal supervision in a federal client environment Security & Eligibility Requirements - Ability to obtain and maintain a federal Public Trust (suitability) clearance - U.S. Citizenship or Permanent Residency required (no visa sponsorship available) Benefits - Referral Bonus - 401(k) Matching - Eleven Holidays - Technology Reimbursement - Short-Term & Long-Term Disability - Life Insurance (Basic, Voluntary & AD&D) - Paid Time Off: 15 days PTO for 0–3 years, 20 days PTO for 3+ years - 80% Employer Paid Health Care Plan (Medical, Dental & Vision) Salary: $90,000–120,000 (commensurate with experience) Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status. Only direct applicants will be considered. Submissions from recruiting or staffing firms will not be accepted.
Technology

LTS
VistA Subject Matter Expert
Senior
Remote
🏢 Summary: Senior VistA Subject Matter Expert role supporting a VA healthcare modernization initiative focused on AI-powered transformation of legacy healthcare systems. The position involves reviewing VistA workflows, MUMPS code, FileMan structures, integrations, and operational processes to ensure accuracy and alignment with VA standards while supporting modernization, interoperability, and migration efforts. 🗂️ Requirements: Bachelor's degree in Information Technology, Healthcare Administration, Computer Science, Engineering, or related discipline, 8+ years supporting VA healthcare systems and VistA environments, Hands-on experience writing RPCs and exporting VistA data, Deep knowledge of VistA architecture and MUMPS-based applications, Experience supporting healthcare IT systems in federal healthcare environments, Strong understanding of VA clinical and operational workflows, Experience with modernization, migration, or integration of legacy healthcare systems, Knowledge of healthcare interoperability standards and enterprise integration concepts, Ability to analyze complex healthcare business and technical requirements, Strong communication and stakeholder engagement skills 📃 Skills: VistA, MUMPS, FileMan, RPCs, HL7, FHIR, CPRS, Cache, InterSystems, DevSecOps, Agile 🏢 Description: LTS is seeking an experienced VistA Subject Matter Expert (SME) to support a major AI-powered modernization initiative within the Department of Veterans Affairs (VA) health portfolio. This role will provide deep functional and technical expertise supporting legacy VistA environments, healthcare workflows, and modernization initiatives tied to mission-critical Veteran healthcare systems. The ideal candidate will possess extensive knowledge of VA healthcare systems, VistA architecture, MUMPS-based applications, and clinical or operational workflows within the VA healthcare ecosystem. This individual will serve as a trusted advisor to program leadership, architects, engineers, analysts, and government stakeholders supporting modernization, interoperability, and transformation efforts across enterprise healthcare platforms. A primary function of this role is reviewing generated code, documentation, workflow analyses, and process outputs for accuracy, completeness, and correctness against actual VistA behavior and VA operational standards—serving as the authoritative check on whether outputs reflect how VistA truly works before they are used to drive design or development decisions. What You'll Do: - Provide subject matter expertise supporting VA VistA systems, workflows, and modernization initiatives. - Review generated MUMPS code, Fileman definitions, business rules extractions, and system documentation for accuracy and completeness, identifying errors, omissions, or misrepresentations against actual VistA behavior and VA configuration before outputs are used by development or architecture teams. - Review generated workflow diagrams, process documentation, and clinical or administrative procedure descriptions for correctness against actual VA operational practices, flagging gaps or inaccuracies that could affect modernization design decisions. - Advise technical and program teams on VistA architecture, functionality, dependencies, and operational processes. - Support analysis and modernization of legacy MUMPS-based healthcare applications and integrations. - Collaborate with architects, developers, infrastructure teams, and business stakeholders to support modernization and migration strategies. - Assist with requirements gathering, workflow analysis, and system impact assessments related to VistA environments. - Support interoperability initiatives involving legacy and modern healthcare systems. - Provide expertise related to clinical, administrative, and operational healthcare processes supported within VistA. - Assist with troubleshooting, root cause analysis, and resolution of complex VistA-specific issues including MUMPS code defects, Fileman data anomalies, RPC failures, and VA configuration problems. - Support data mapping, interface analysis, and integration efforts involving VistA Fileman structures, MUMPS globals, RPCs, and VA-specific data configurations and enterprise systems. - Participate in modernization planning sessions, architecture reviews, MUMPS and modernized code reviews, interface design reviews, testing activities, and implementation efforts. - Develop and review technical documentation, workflow diagrams, process documentation, and operational procedures. - Support stakeholder communication and provide guidance to both technical and non-technical audiences regarding VistA-related functionality and modernization impacts. - Assist with knowledge transfer and mentoring activities across project teams. What We're Looking For: - Bachelor's degree in Information Technology, Healthcare Administration, Computer Science, Engineering, or related discipline; equivalent experience may be considered. - 8+ years of experience supporting VA healthcare systems and VistA environments, including hands-on experience writing Remote Procedure Calls (RPCs) and exporting VistA data. - Deep knowledge of VistA architecture, workflows, and MUMPS-based applications. - Experience supporting healthcare IT systems within complex federal healthcare environments. - Strong understanding of VA clinical and operational workflows. - Experience supporting modernization, migration, or integration initiatives involving legacy healthcare systems. - Knowledge of healthcare interoperability standards and enterprise integration concepts. - Ability to analyze complex healthcare business and technical requirements. - Strong communication and stakeholder engagement skills. Nice to Have: - Experience supporting VA EHR modernization (EHRM) or VistA Evolution initiatives. - Familiarity with CPRS, FileMan, Cache/InterSystems, HL7, FHIR, and healthcare integration technologies. - Experience supporting healthcare data analysis, interface mapping, or enterprise integration efforts. - Knowledge of Agile delivery methodologies and DevSecOps environments. - Experience collaborating with technical architecture and software development teams. - Prior experience supporting federal healthcare modernization or digital transformation initiatives. - Relevant VA, healthcare IT, or project management certifications preferred. Pay Range $178,000—$198,000 USD LTS shares salary ranges to promote transparency. Compensation ranges are provided for informational purposes, and final compensation may vary based on experience, skills, location, and role requirements. LTS is committed to offering eligible employees comprehensive benefits that will provide them with options intended to meet their needs and the needs of their family.
