Product Development Engineer II
Core
Develop, document, test, and debug medical devices, test fixtures, and data collection systems for insulin pumps.
Role type
Product Development Engineer II (Mechanical)
Builds
Medical device components, test fixtures, and pilot assembly lines for insulin pumps.
Domain
Medical devices / Insulin pumps
Required skills
Mechanical design, SolidWorks, GD&T, root cause analysis, statistical analysis, process validation, component selection, vendor management
Preferred skills
QSRs, ISO 14971, IEC 60601, medical device design, CNC machining
Technologies
SolidWorks, CNC
Responsibilities
Conduct mechanical design of medical devices and fixtures; manage design verification and validation activities; investigate and resolve design non-conformances; plan and develop pilot assembly lines; select components and equipment based on reliability analysis; develop and manage testing at external facilities.
Seniority
Mid-level, hands-on IC