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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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With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you'll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow.Job Description: Perform engineering duties of planning, designing, installing, and maintenance of electrical systems for the plant facility & operations areas. Improve the energy efficiency of operating infrastructure & manufacturing equipment to reduce the overall energy costs. Manage and coordinate small and large engineering projects. Job Functions: Estimate, plan, design, and implement the construction and maintenance of plant infrastructure. Specify equipment and systems to support plant infrastructure and facility processes. Troubleshoot and solve problems related to the plant infrastructure and facility processes. Support plant infrastructure and facility process equipment which includes, but is not limited to: boilers, compressors, chillers, HVAC systems, electrical distribution systems (15kV, 480V, 120V), standby generator & UPS systems, fiber optic & Ethernet communication systems, Life Safety systems (smoke & fire detection, annunciation & notification, fire suppression), security systems (card access, camera, gate control), lighting. Plan & coordinate work with skilled in-house tradesman & supervisors, as well as outside contractors & service technicians. Provide and implement designs for electrical infrastructure equipment and systems. Working knowledge & practical use of National Electric Code (NFPA) & NFPA 70E Standard for Electrical Safety in the Workplace. Participate in teams and cross-functional groups. Work on multiple projects simultaneously with minimal supervision. Project management and plant engineering functions. Candidate Requirements: BS degree in Electrical Engineering or Electrical Engineering Technology (or equivalent), and at least five years Plant Engineering or Facility Engineering experience. Computer Skills: Microsoft Office (Word, Excel, PowerPoint), AutoCAD. Effective oral and written communication skills. High level of interpersonal skills to work effectively with others. High level of analytical ability to solve complex problems. Ability to interpret prints and drawings. Understanding of building, infrastructure, and utility functions. Ability to work in an industrial work environment ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status. Please beware of job seeker scams and see this important notice on our careers page for more information about our recruiting process. Compliance Notice: Alten USA is a federal contractor subject to the requirements of the Vietnam Era Veterans' Readjustment Assistance Act (VEVRAA) and Executive Order 11246. We are an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Drug Screening Requirement: As a federal contractor, Alten USA maintains a drug-free workplace. All candidates selected for employment will be required to successfully complete a pre-employment drug screening as a condition of hire.

Technology

ALTEN

Mechanical Integration Engineer

Senior

On-site

Foster City, CA

🏢 Summary: Hybrid Harness / Mechanical Integration Engineer role focused on low-voltage electrical system integration in vehicles, combining harness routing, mechanical packaging, and hands-on prototype support. The position involves end-to-end ownership of routing strategies, mechanical retention design, CAD documentation, and build validation in real vehicle environments. Ideal for an independent engineer experienced in constrained vehicle integration and fast iteration cycles. 🗂️ Requirements: Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related field, 5+ years of experience in automotive, robotics, aerospace, or similar industries, Strong experience with harness routing and mechanical packaging in constrained vehicle environments, Proficiency in CAD tools and creation of 2D drawings, Experience driving designs through release and change control processes, Understanding of DFM/DFA and tolerance stack-ups, Knowledge of manufacturing methods: sheet metal, machining, injection molding, additive prototyping, Practical knowledge of harness integration best practices (bend radius, strain relief, chafe protection, heat avoidance), Ability to independently own integration problems and deliver manufacturable solutions, Experience supporting prototype builds and working directly with hardware and technicians 📃 Skills: CAD, CATIA, NX, SolidWorks, GD&T, DFM, DFA, PLM, ECO, CAN, LIN, EMC, SiemensCapital, 3DX 🏢 Description: Location: Foster City, CA We're looking for a highly self-sufficient engineer who can operate as a hybrid Harness / Mechanical Integration Engineer to enable fast, safe, and serviceable implementation of low-voltage electrical systems in vehicles. This role bridges harness routing/retention and mechanical packaging, focusing on practical solutions such as brackets, clips, clamps, channels, strain relief, and protective features to ensure electrical components and harnesses can be installed reliably in real vehicles. The ideal candidate can independently take loosely defined integration problems, drive the design to a manufacturable solution, and support prototype builds with minimal guidance. Responsibilities • Own end-to-end harness mechanical integration for assigned vehicle areas: define routing/retention strategy, identify constraints, and drive implementation through release and build support • Independently design and iterate mechanical retention solutions for harnesses and LV components (brackets, clamps, clips, tie features, channels, grommet interfaces, protective covers, strain relief) with clear installation intent • Lead packaging and routing studies in-vehicle: measure, model, manage clearances, avoid chafe/heat/sharp edges, ensure service access, and account for build variation and tolerance stack-ups • Create complete CAD and release-ready documentation: ○ 3D CAD + 2D drawings for brackets/mounts/retainers (GD&T as needed) ○ Harness routing/retention definition and installation guidance sufficient for technicians and build teams ○ BOMs, fastener specs, torque requirements, and assembly steps • Coordinate and support prototype builds / fit-checks: drive fast design loops to closure based on real vehicle feedback • Proactively identify integration risks (rattles, loosening, chafe, interference, thermal proximity, ingress, accessibility) and implement prevention strategies • Partner with EE, Vehicle System Integration, Vehicle Integration, Geometric Integration and Manufacturing to deliver stable, serviceable solutions Qualifications • Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related field with 5+ years' experience in automotive/robotics/aerospace or similar • Demonstrated ability to work independently and deliver with minimal oversight • Strong hands-on experience with harness routing/retention and/or mechanical packaging in constrained vehicle environments • Proficiency with CAD (e.g., CATIA, NX, SolidWorks) and 2D drawings; comfortable driving designs through release/change control • Solid understanding of DFM/DFA, tolerance stack-ups, and manufacturing methods (sheet metal, machining, injection molded clips, additive prototyping) • Practical knowledge of harness integration best practices: bend radius, strain relief, branch management, clip spacing, chafe protection, heat avoidance, edge protection, grommet usage, service loops, installation sequencing • Comfortable working directly with hardware, vehicles, and technicians in fast iteration cycles • Strong communication and documentation skills Bonus Qualifications • Master's degree in Mechanical Engineering or Electrical Engineering • Experience with harness design tools (e.g., Siemens Capital, CATIA/3DX, NX) and release workflows (PLM, ECO/CR) • Familiarity with automotive networks and electrical integration constraints (CAN/LIN routing considerations, grounding, EMC-sensitive routing) • Experience defining fastener strategy and durability considerations (vibration, corrosion, thermal, ingress/IP needs) • Experience building or supporting test fixtures / special equipment for lab or vehicle work Salary Range • $110,000–120,000 • Actual salary dependent on experience, skills, and qualifications Compliance Notice Alten USA is a federal contractor and Equal Opportunity Employer. All candidates selected for employment must successfully complete a pre-employment drug screening as a condition of hire.