Senior Mechanical Engineer

Senior Mechanical Engineer

Vacancy expired!

Our client is seeking a Senior and Principal level Mechanical Engineer. The senior level role will be a major technical contributor. The Principal Engineer will play a dual role between technical responsibilities and could offer a track into mechanical engineering management at some point. Both of these are direct hire openings in St Paul, MN. Past medical device experience is preferred.

Position Responsibilities:

• Leading a multi-disciplinary design team for medical device capital systems and/or integrated SUDs (single use devices) to the successful completion of project goals


• Performing Verification and Validation (V&V) of both capital system and single-use medical devices


• Creating and managing a schedule of technical deliverables in coordination with a project manager


• Translating highly technical results into easily understood recommendations that will influence cross-functional and Principal stakeholders.


• Creating engineering documentation such as Design Requirements, drawings, BOMs, test methods, and technical reports, and coaching others on engineering documentation


• Training and/or providing work direction to technicians and less experienced engineers


• Successful completion of engineering work in product design and development, test methods, research investigation (animal and clinical studies), and report preparation


• Demonstrated knowledge of medical device design controls through coaching and delivery of high quality, high impact deliverables.


• Lead efforts to design in design for manufacturability, test and cost for medical devices.


• Maintain and ensure compliance with design and quality controls


• Interface with customers and business development

• 7+ years product development in lead roles, preferably in medical device industry


• Mechanical Engineering degree or BME with a focus on ME. Bachelors required; Masters preferred


• Demonstrated track record of medical device product development from concept to commercialization.


• Experience within fluids and/or heat transfer would be ideal


• Excellent hands-on mechanical prototyping, debugging, verification, and failure analysis skills


• Working knowledge of mechanical design principles and FDA regulated medical device design controls


• Proficient in CAD software, preferably SolidWorks