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Risk Management (Medical Devices)

Indianapolis, Indiana, United States

We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life-saving medical devices to building autonomous electric vehicles. 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.

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.
  • Reviewing and structuring existing FMEAs currently in Excel
  • Reformatting data so it can be integrated into Turbo AC (their risk management tool)
  • Supporting the upcoming import process and ensuring everything is properly structured
  • Assisting 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
    • 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.

Work Authorization Requirement: Due to client requirements, only candidates who are U.S. Citizens or U.S. Permanent Residents (Green Card holders) are eligible for consideration for this position.

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age, genetic information, or pregnancy.

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.

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