Staff R&D Test Engineer

Job description

Work Flexibility: Hybrid What You Will Do: - Design, develop, and validate custom benchtop test methods to characterize product performance - Develop, execute, and document test protocols and reports to support product development, verification, validation, and regulatory submissions - Design and validate test methods, including Test Method Validation (TMV) and Gage R&R studies - Analyze test data using statistical tools (e.g., Minitab, JMP) and lead structured problem solving for test or product-related issues - Implement continuous improvement initiatives, leveraging lean principles and automation to reduce variability and testing cycle time - Support root cause investigations, CAPAs, and change control through structured test analysis - Maintain and develop custom test fixtures and simulated-use models, ensuring physiological relevance for neurovascular applications - Ensure all test activities are executed in compliance with applicable standards (e.g., ISO 10555, ISO 14971, ISO 13485, FDA 21 CFR Part 820) What You Will Need: Required Qualifications: - Bachelor’s in Engineering or related discipline - 4+ years of experience in a medical device or other regulated environment - Pr...