Job Description

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.

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