Clinical Test Engineer
StrykerAbout the role
As a 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.
- Support development robust verification and validation test strategies to ensure a safe, reliable product is being developed.
- Collect benchtop R&D data.
- You will collaborate with New Product Development and 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
- Support 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
- 0+ years experience
Preferred Qualifications:
- Project or internship experience in clinical engineering, design engineering or test engineering
- Knowledge of Risk Analysis, Design V&V testing, Root Cause Analysis, Statistics, and practical applications
- 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 and/or understanding of human anatomy and surgical procedures/techniques
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