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.
• 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 606011, 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 inSystems Engineering methodologies.
• Expertise with key standards, including:
  • ISO 14971
  • ISO 11608
  • IEC 606011 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.