A company is looking for a Medical Device Systems Engineer.
Key Responsibilities
Manage device design changes by collaborating with cross-functional teams and assessing the impact of design changes on electromechanical drug delivery devices
Conduct verification testing, including planning, fixture development, and test execution
Lead multiple concurrent projects and propose device refinements based on stakeholder feedback
Required Qualifications
Bachelor of Science degree in Engineering with 5+ years of experience in medical device development
Graduate degree in a technical or scientific field is preferred
Experience with infusion systems (pumps and disposables) and electro-mechanical medical devices
Proficiency in traceability and requirements management
Experience with medical device EU and FDA submissions, product launch, and compliance with relevant regulations
System Engineer • Dorchester, Massachusetts, United States