Job Description
The Test Engineering Lead will be responsible for leading all aspects of design verification, validation, and system-level testing for a Class II medical device. This role ensures that the device meets its design requirements, regulatory standards (FDA, ISO 13485, IEC 60601, etc.), and intended clinical performance. The ideal candidate combines strong technical expertise in electromechanical and/or optical systems with a deep understanding of regulatory compliance and test methodology for medical devices.
Key Responsibilities:
Test Strategy and Planning:
- Develop and lead the Design Verification and Validation (V&V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971).
- Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.
- Ensure traceability of test activities to design inputs, risk contr...