Risk Management (Medical Devices)

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.

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. , consistency between RCMs and design inputs). ).

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.

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.

Requirements

S. 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.

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