Senior Clinical Test Engineer
Senior Clinical Test Engineer
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1 Vacancy
Job Description
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 youll be part of a talented team developing advanced AI and computer visionbased 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 to ensure proper disposition.
- Ensure compliance with regulatory and system quality requirements
- Lead postmarket surveillance of products to identify clinical needs ensure proper device use and risk mitigation.
What You Need:
Required Qualifications:
- Bachelors 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
Required Experience:
Senior IC
Employment Type
Full-Time
