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Senior Medical Device Risk Lead Systems Engineering

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: Altentechnologyusa
Full Time position
Listed on 2026-07-13
Job specializations:
  • Engineering
    Biomedical Engineer, Medical Device Industry
Salary/Wage Range or Industry Benchmark: 110000 - 160000 USD Yearly USD 110000.00 160000.00 YEAR
Job Description & How to Apply Below
Position: Senior Medical Device Risk Lead with Systems Engineering
Location: Indianapolis

Alten USA is seeking a Risk Management SME with extensive medical device risk management and Systems Engineering background to support development, review, and technical assessment of key risk management deliverables for a medical device program.

The role covers PHA technical reviews, platform CHA/BE CHA, platform risk libraries, alignment with Systems Engineering deliverables, and compliance with ISO 14971, ISO 11608 and IEC 60601‑1.

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Position Requirements
10+ Years work experience
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