Mechanical Design Engineer II

Minneapolis, Minnesota | Medical Device Industry

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We are seeking for a Mechanical Design Engineer II for a very important client.

The Mechanical Design Engineer II will support the design of implantable leads, catheters, and related accessories. The primary areas of excellence for this position are generation of measurable and verifiable product specifications, generation and evaluation of corresponding product designs and BOM’s, and transfer of product designs into a manufacturing environment supporting product commercialization.

Responsible for product design from conception through product retirement; Lead the determination of system level objectives and work in cross-functional teams. This position requires frequent contact with other functional areas i.e. business development, clinical, marketing, regulatory, manufacturing and suppliers. Work under minimal supervision.

Develops technical solutions to complex problems that require ingenuity and creativity. Applies high-level technical expertise and has strong knowledge of other related disciplines. Guides the successful completion of product design initiatives. Exercises considerable latitude in determining technical objectives of the assignment.

The ideal candidate will possess the following skills:

-B.S. in engineering or appropriate technical discipline (Mech Eng, Materials Science, Chemical Eng. or equivalent);

-Minimum of 5 years in design of implantable medical products

-Strong knowledge of technology, product development, manufacturing, clinical, and regulatory requirements;

-Strong Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA; Experience using and FMEA and FTA methods;

-Proficient with Pro/Engineer software or equivalent CAD software;

-Knowledge of lab practices, procedures, and tools/equipment.

The preferred requirements of this position include those already listed in the Basic Qualification, plus:

-Knowledge of spinal and brain anatomy/physiology. Deep experience interfacing with physician customers and therapy consultants/sales;

-Experience in a manufacturing environment; cross-functional technical experience; industry knowledge.

-Master’s Degree in engineering or appropriate technical discipline (Mech. Eng, Materials Science, or equivalent).

-Experience with CAPA (corrective and preventative action) and continuation projects in a medical device environment.

-12 plus years’ experience in product development.

-8 plus years’ experience in design of implantable medical products.

-Proficient with DFSS principles (VOC, Transfer Functions, etc.) as they relate to designing robust products.

-DFLS or DFSS Green Belt certification.