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Sr. Mechanical Design Engineer
Job Number: #2017-26
Location: St. Paul, MN

EnteroMedics is looking for a Sr. Mechanical Design Engineer who will be responsible for creating innovative, functional, and robust product designs for Class III active implantable medical devices using state of-the-art techniques and tools. Primary responsibility is to design, prototype and test the systems mechanical components with emphasis on the implantable neuroregulator, external charger, and leads. The Sr. Mechanical Design Engineer will provide design, solid modeling and analytical support for the development of the product.

ESSENTIAL FUNCTIONS

  • Provide conceptual design, detail design and prototyping, supplier selection, performance testing, and project management.

  • Partner with manufacturing, marketing, quality, and regulatory to ensure that the final product meets customer requirements, as well as company performance, schedule, and cost targets.

  • Provide mechanical design and analysis support for various research-based preclinical test systems.

  • Plan, create, analyze, and refine mechanical designs using SolidWorks 3-D solid modeling and document the designs with specifications and drawings.

  • Evaluate physical design using rapid prototyping.

  • Develop product specifications and test protocols.

  • Support development of requirement documents and production test requirements as well as production test development.

  • Plan and perform product evaluation testing traceable to system level requirements.

  • Design and qualify test methods, analyze and communicate test results and rationale behind design decisions to other development team members and management staff, and generate test reports.

  • Coordinate compliance testing with outside test services.

  • Participate with cross-functional development team members in performing risk analysis, FMEA (failure modes and effects analysis), FEA (finite element analysis), DVT (design verification testing), DFM (design for manufacturability), and tolerance analysis.

  • Evaluate suppliers, consultants, and technical experts and make necessary recommendations. Work with suppliers to create new designs and/or processes.

  • Provide work direction and coordinate activities for CAD Designer and R&D technicians.

  • Adhere to EnteroMedics Design and Development Standard Operating Procedures (SOPs) and maintain design history file.

  • Work within the constraints of EnteroMedics configuration management and change order system.

  • Perform returned product analysis as well as packaging design, test fixture design, test method development, and support for product testing and inspection from time to time.

MINIMUM REQUIREMENTS

  • Master’s degree in Mechanical Engineering is preferred; a bachelor’s degree is acceptable provided the individual possesses the requisite design experience.

  • 10+ years mechanical design experience working with medical devices is required in addition to a proven track record of bringing medical products from initial concept design through commercialization.

  • Deep understanding of materials and processes commonly used in the development of medical products. Thermoplastic molded part design experience is required.

  • Experienced user of solid modeling systems and related analytical tools. Experience in file transfer to suppliers for rapid prototyping, mold flow analysis, mold construction, and other similar activities in addition to design for manufacturability experience.

  • Knowledge and understanding of how system requirements including product packaging and labeling impact the overall product design

  • Broad knowledge of all aspects of mechanical engineering involved in the development of active implantable medical devices including medical product safety standards, biocompatibility, and regulatory requirements.

  • Working knowledge of statistical analyses and basic computer knowledge including MS Word, Excel, and Project.

  • Must be flexible in responsibilities, an excellent communicator, both written and orally, and an exceptional problem solver with the ability to implement appropriate solutions.

 If you are interested in applying for this position, please fill out this form to submit your resume.