Senior Engineer, Test

• Develop and implement comprehensive design verification strategies for medical device development projects, ensuring all design inputs are verified through appropriate methods. • Create high-level verification plans that define scope, methods, acceptance criteria, and traceability from design inputs to verification protocols and reports. • Lead test readiness reviews (TRRs) to ensure protocols, fixtures, equipment, and samples are ready before verification execution. • Design, develop, and validate test methods for design verification, including test instructions, validation protocols, execution, and validation reports. • Develop clinically relevant test methods that ensure design requirements are sufficiently verified, collaborating with cross-functional partners. • Validate test equipment and test methods to ensure measurement accuracy, repeatability, and reproducibility. • Design, build, qualify, and maintain electro-mechanical test tools, fixtures, jigs, and test benches based on design input requirements to support automated and manual testing. • Execute Installation Qualification (IQ) and Operational Qualification (OQ) for custom test fixtures and equipment. • Generate and execute test protocols for design verification, feasibility assessments, and reliability/life testing across mechanical, electrical, and system-level domains. • Conduct extended reliability tests, accelerated life testing (ALT), and test-to-failure studies to characterize design robustness. • Analyze test data using appropriate statistical techniques and document results in verification reports. • Write technical reports including test assessments, design verification protocols, deviation investigations, and verification summary reports for the Design History File (DHF). • Ensure full traceability from design inputs, verification protocols, test results and verification reports. • Contribute to documentation for regulatory submissions (510(k), CE Mark Technical File) and maintain audit-ready records. • Collaborate with product development teams (mechanical, electrical, systems, firmware software) to characterize new hardware designs and emerging technologies. • Work with Quality, Regulatory, and Manufacturing teams to ensure compliance with medical device standards (ISO 13485, IEC 60601, FDA 21 CFR 820). • Ensure all verification activities comply with FDA 21 CFR 820.30(f) design verification requirements, ISO 13485 design controls, and global regulatory standards. • Support regulatory and agency submissions by providing verification data and reports. • Other ad-hoc tasks assigned by immediate supervisor.