Senior Clinical Test Engineer

As a Senior Clinical Test Engineer with Stryker, you will be responsible for developing and executing robust verification and validation test strategies. In this role, you'll be part of a talented team developing advanced AI and computer vision-based medical technologies for the operating room. You will serve as the key link between the Clinical Engineering Lab and NPD teams.

Check out our product portfolio: Stryker Surgical Technologies

This role is hybrid located in Portage, MI with the opportunity to work from home on occasion.

What you will do:

• Review and evaluate project requirements documentation as well as apply sound technical competence to ensure we are delivering robust products.
• Work with internal NPD teams to provide input into product development and sustainability based on observed user needs. 
• Provide input throughout the new product development process from a test perspective.
• Develop robust verification and validation test strategies to ensure a safe, reliable product is being developed.
• Collect benchtop R&D data for new products or projects.
• Manage large data repositories in a complete and accurate form following good documentation practices.
• You will collaborate with other functional areas to ensure a comprehensive test strategy is developed that ensures the highest quality and performance of our products.
• Generate and review appropriate test protocols to properly test the product and ensure accuracy in test reports.
• Perform development and/or verification testing.
• Document and track defects found during test execution to ensure proper disposition.
• Ensure compliance with regulatory and system quality requirements
• Lead post-market surveillance of products to identify clinical needs, ensure proper device use and risk mitigation.

What You Need:

Required Qualifications:

• Bachelor's degree in biomedical engineering, biological sciences or related engineering degree.
• 2+ years experience
• 1+ years experience clinical engineering, design engineering, quality engineering or test engineering
• Knowledge of Risk Analysis, Design V&V testing, Root Cause Analysis, Statistics, and practical applications

Preferred Qualifications:

• Understanding of human anatomy and surgical procedures/techniques
• Experience with medical device test method development
• Knowledge of FDA, ISO, and other regulations and standards
• Experience developing software using ISO 13485 quality practices
• Experience working with surgeons and other healthcare providers in a hospital setting