Staff R&D Test Engineer

Stryker • Fremont, CA

1d • $116,000 - $193,000 • Hybrid

About The Position

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)

Requirements

• Bachelor’s in Engineering or related discipline
• 4+ years of experience in a medical device or other regulated environment
• Proficient in test method development, Test method validation, Gage R&R, and statistical data analysis
• Hands-on knowledge of test equipment such as Instron, pressure systems, flow loops, and tensile/fatigue testers
• Strong documentation practices and understanding of design control, risk analysis (ISO 14971), and validation procedures

Nice To Haves

• Experience with liquid embolics, catheter, stent, or guidewire-based devices, ideally in neurovascular or cardiovascular domains
• Familiarity with LabVIEW, MATLAB, or Python for data acquisition and control
• Experience with SolidWorks or similar CAD for fixture development

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees