Lead Design Assurance Engineer

The Lead Design Assurance Engineer is responsible for following established GMP/ISO compliant quality system practices. Duties: 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 file. 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. Qualifications: Bachelor’s or Master’s degree and 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.

#LI-KH1