Senior Engineer, Design Validation - $6K

Senior Engineer, Design Validation * Develop and maintain a project-specific Design Validation Plan that defines scope, methods, sample sizes, and acceptance criteria, ensuring alignment with user needs and intended use. * Develop and execute design validation (DV) protocols and reports for design and development of medical devices. * Ensure traceability from user needs design requirements, validation protocols, validation reports within the Design History File (DHF).

* Design and execute validation studies on initial production units (or equivalents) under defined operating conditions that reflect real-world clinical use. * Conduct simulated-use testing with representative users (e.g., surgeons, OR nurses) to confirm the device meets user needs in actual clinical workflows. * Lead human factors engineering activities, including formative and summative usability studies, to verify safe and effective use by intended users.

* Develop use scenarios, task analyses, and use-related risk assessments to inform validation protocol design. * Ensure compliance with IEC 62366 (usability engineering) and FDA human factors guidance for medical devices. * Plan and execute clinical evaluation activities (e.g., cadaver studies, animal studies, or clinical trials) as needed to validate device safety and effectiveness. * Perform other ad-hoc duties as assigned by immediate supervisor.

Requirements * Bachelor's degree in Biomedical engineering, Mechanical Engineering, Electrical Engineering, or related field with 6–9 years of experience in design validation, design quality, or V&V engineering within the medical device industry, with at least 2 years focused specifically on design validation activities. Salary: Up to $6K Location: East of Singapore Interested candidates are welcome to email resume to [email protected] and CC to [email protected]