Senior Clinical Test Engineer

Work Flexibility: Onsite

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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.