Product Development Engineer

The Engineer II will participate in the design & development of medical devices that are both safe and effective, under the leadership of senior staff. Engineers at this level must have prior relevant experience in the medical device industry and are expected to be able to work under general supervision on moderately complex engineering assignments, while generating regulatory compliant documentation for inclusion in the medical device’s design history file.

· Solving moderately complex engineering problems

· Generating novel / innovative medical device design concepts

· Creating regulatory compliant documentation for inclusion in the design history file, including protocols & reports

· Design verification & design validation activities

· Statistical analysis of test results

· Translating design inputs to design outputs

· Taking part in and generating documentation for cross-functional risk management activities

· Presenting work (designs / test results / etc.) at cross-functional design reviews

· Other duties as required

· Bachelor’s degree in mechanical engineering, or equivalent

· Proficient in CAD (SolidWorks preferred), MS office

· Proficient in design of injection molded plastic parts / assemblies

· At least one-year relevant experience in the medical device industry

· High attention to detail

· Ability to work collaboratively with other departments

· Working conditions are normal for an office environment

· Work may require weekend and evening work

· Work may require travel

· Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 lbs

· Work under stress in a fast-paced environment