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
• 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

Preferred Qualifications:

• 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

• $116k - $193k salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.