Lead Design Assurance Engineer
The Fountain Group · Pleasanton, CA · 1 mo ago
On-siteOTHRContract
About the role
Responsible for following established GMP/ISO compliant quality system practices.
Responsibilities
- Lead design assurance activities in support of development for risk management files (Hazard Analysis, FMEA, Risk Management Planning, Risk Management Report, Benefit Risk Analysis) per ISO 14971 guidelines.
- Manage new risk management files.
- Work with Engineering, Marketing, Manufacturing, and Regulatory to establish risk management files.
- Understand test plan protocols, test procedures, and test reports used for risk controls.
- Understand design verification and design validation plans and links to the risk management files.
- Understand implication of risk management in Verification and Validation sampling plans.
- Able to lead technical discussions of products and associated risk management documentation.
Requirements
- Bachelor’s or Master’s degree.
- Minimum 5+ years’ experience in Medical Device Design Assurance / Quality Engineer roles with deep hands-on ISO 14971 risk management experience, including ownership of Risk Management Files, FMEA/Hazard Analysis, and strong understanding of Design Controls and V&V.
- Strong understanding of how risk management integrates into the medical-device development lifecycle: Design Controls → Risk Analysis → Risk Controls → Design Inputs/Outputs → Verification & Validation → Traceability.