Lead Design Assurance Engineer

The Fountain Group; Pleasanton (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Job summary

The Fountain Group is seeking a Lead Design Assurance Engineer to drive risk management activities for medical device development. You will own risk management files, work with Engineering, Marketing, Manufacturing and Regulatory, and ensure design controls and V&V are integrated throughout the lifecycle.

The role requires a strong background in ISO 14971 risk management with hands-on experience in design assurance and quality engineering.

Qualifications

• Bachelor’s or Master’s degree with 5+ years in medical device design assurance or quality engineering.
• Deep hands-on ISO 14971 risk management experience and ownership of Risk Management Files.
• Strong understanding of Design Controls and V&V across product lifecycle.

Responsibilities

• Lead risk management activities for development per ISO 14971.
• Manage new risk management file.
• Collaborate with Engineering, Marketing, Manufacturing and Regulatory.
• Interpret test plans and reports used for risk controls.
• Link design verification and validation plans to risk management.
• Lead technical discussions of products and risk documentation.

Skills

Design Assurance

Risk Management

FMEA

ISO 14971

Design Controls

V&V

Cross-functional collaboration

Education

Bachelor’s or Master’s degree

Job description

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.

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