Clinical Test Engineer

Stryker Employment Company • Portage, MI

282d • Remote

About The Position

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.

Requirements

• Bachelor's degree in biomedical engineering, biological sciences or related engineering degree.
• 0+ years experience.

Nice To Haves

• 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.

Responsibilities

• 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.
• 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 This Job Offers

• Education Level: Bachelor's degree