Risk Management Specialist
About The Position
ALTEN Technology USA is seeking a Risk Management Subject Matter Expert (SME) with extensive medical device risk management experience and a strong Systems Engineering background. The consultant will support the development, review, and technical assessment of risk management deliverables for a medical device program. The role includes reviewing and structuring existing FMEAs in Excel, preparing data for integration into Turbo AC, supporting the import process, and manually linking hazards to FMEAs after upload. The position requires on-site presence in Indianapolis. Due to client requirements, only U.S. citizens and U.S. permanent residents (Green Card holders) are eligible. Candidates selected for employment must successfully complete a pre-employment drug screening.
Requirements
- At least 8 years of experience in medical device Risk Management.
- Strong background in Systems Engineering methodologies.
- Expertise with ISO 14971.
- Expertise with ISO 11608.
- Expertise with IEC 60601-1 and related standards.
- Ability to conduct detailed and complex technical analyses.
- Excellent technical documentation and writing capabilities.
- High attention to detail and a strong analytical mindset.
- Ability to collaborate effectively with cross-functional teams.
- Must be a U.S. citizen or U.S. permanent resident (Green Card holder), due to client requirements.
- Must successfully complete a pre-employment drug screening as a condition of hire.
- Must be able to work on site in Indianapolis.
Nice To Haves
- Experience with Turbo AC or other risk management platforms.
Responsibilities
- Conduct technical review of the PHA.
- Support development and technical review of the BE CT CHA and platform CHA, including associated platform risk libraries.
- Ensure alignment with Systems Engineering deliverables, including consistency between RCMs and design inputs.
- Verify that risks and RCMs align with applicable standards, including ISO 11608 and IEC 60601-1.
- Support integration activities related to platform risk libraries.
- Contribute to development and review of the Platform Risk Management Plan (RMP).
- Participate in Functional Failure Analysis, including identifying system-level effects and assigning appropriate defect classifications.
- Support additional Risk Management deliverables throughout the project lifecycle.
- Review and structure existing FMEAs currently maintained in Excel.
- Reformat data for integration into Turbo AC.
- Support the upcoming import process and ensure data is properly structured.
- Assist with manual linking between hazards and FMEAs once uploaded.
- Collaborate with Systems Engineering, Quality, Design, and Platform Engineering teams.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
