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.