Lead Design Assurance Engineer

The Lead Design Assurance Engineer is responsible for following established GMP/ISO compliant quality system practices.

• 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.

• 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.

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