Medical Device Prototype Engineer

Job Title : Medical Device Prototype Engineer

Location : St. Paul, MN

Experience : 7+ years

Duration : 12+ Months

Job Overview :

We are seeking a highly skilled Medical Device Prototype Engineer with extensive experience in designing, constructing, and evaluating prototype printed circuit boards, tools, and fixtures. The ideal candidate will have a strong background in electrical engineering, hands-on experience with prototype development, and familiarity with FDA regulations. This role requires both independent problem-solving and collaboration across cross-functional teams in a fast-paced, matrixed environment.

Key Responsibilities :

Design, layout, and construct a variety of prototype tools, fixtures, and printed circuit boards for development purposes.

Conduct evaluations, tests, and analyses to determine feasibility, performance, and functionality.

Perform troubleshooting, fault isolation, and measurements on breadboards and hybrid circuits.

Document tools and prototypes, including specifications, schematics, and mechanical layouts, to support tool release and document control.

Conduct engineering tests according to design verification plans, tabulate results, and prepare comprehensive reports.

Ensure compliance with FDA regulations, other regulatory requirements, company policies, procedures, and processes.

Collaborate effectively with employees, customers, contractors, and vendors at all organizational levels.

Participate in cross-functional projects and contribute to continuous improvement initiatives.

Qualifications :

Bachelor's Degree in Electrical Engineering or related engineering field.

7+ years of relevant work experience in prototype PCB design, tools, and fixture development.

Proven ability to develop new design features within existing systems.

Strong documentation skills with a history of providing engineering information that supports management decisions.

Advanced computer skills, including spreadsheets, word processing, databases, and specialized engineering applications.

Six Sigma knowledge and experience desired.

Professional certification or advanced credentials in a relevant discipline preferred.

Experience in manufacturing processes, preferably in medical device manufacturing.

Ability to work in a matrixed and geographically diverse environment.

Strong verbal and written communication skills at all organizational levels.

Exceptional organizational skills, attention to detail, and ability to prioritize tasks and meet deadlines.