Remote Medical Device Risk Management SME (Systems Eng)

ALTEN Technology USA; Indianapolis (IN); On-site; USD 120,000 - 170,000; Full time

Job summary

ALTEN Technology USA is actively seeking a Risk Management SME with extensive medical device risk management and a solid background in Systems Engineering. The consultant will support development, review, and technical assessment of key risk management deliverables for the medical device program.

Responsibilities include development and review of risk management deliverables, PHA technical reviews, and integration with platform risk libraries, ensuring alignment with Systems Engineering and

Qualifications

• 8+ years of risk management experience in medical devices.
• Strong background in Systems Engineering methodologies.
• Experience with ISO 14971, ISO 11608 and IEC 60601-1.
• Familiarity with risk management platforms such as TurboAC.

Responsibilities

• Develop and review key risk management deliverables for medical device programs.
• Perform technical review of the PHA.
• Support platform CHA and risk libraries integration.
• Ensure alignment with Systems Engineering deliverables and standards.
• Coordinate with cross-functional teams including Quality, Design and Platform Engineering.
• Assist with imports from FMEAs and structuring data for TurboAC.

Skills

Risk management

Systems engineering

Technical writing

Cross-functional collaboration

Tools

TurboAC

Job description

ALTEN Technology USA is actively seeking a Risk Management SME with extensive medical device risk management and a solid background in Systems Engineering. The consultant will support development, review, and technical assessment of key risk management deliverables for the medical device program.

Responsibilities include development and review of risk management deliverables, PHA technical reviews, and integration with platform risk libraries, ensuring alignment with Systems Engineering and