Risk Management (Medical Devices)

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.

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.
• 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

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.

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.