Product Design Engineer

St Paul, MN

Product Design Engineer

Inginaire is seeking a Product Design Engineer for our client located in St. Paul. Our client is a family owned business located south of downtown St. Paul. They have a culture of collaboration, respect and a desire to design and build quality products for their customers.


  • Develop new product concepts following specific Design Control procedures per ISO and FDA utilizing processes
  • Establish product requirements and specifications for these products
  • Coordinate Product Development team to support any new/re-design products
  • Author and coordinate Risk Management activities
  • Meet with and review potential/current suppliers to assess capabilities
  • Create test protocols and acceptance criteria including Product Validation testing
  • Perform testing and document results for final approval
  • Research new product technologies for review/discussion
  • Prepare/Review drawings for engineering, production and quality control as requested
  • Train and assign work direction to any outside suppliers with drawing generation
  • Prepare/Review drawings of existing products to document product specifications as requested
  • Direct necessary changes to improve drawing completeness
  • Assist Instrument Department with necessary information, details, tolerances, for drawing completeness
  • Define manufacturing protocols and materials specifications
  • Coordinate prototyping and evaluation of new product designs
  • Design/Develop/Document Fixtures to aid in assembly and production
  • Investigate product complaints and make recommendations for final determination and corrective action
  • Create formal process documentation such as QSP?s, Work Instructions (WI), Inspection Procedures (IP), Manufacturing Procedures (MP), forms, and get final approvals
  • Create and maintain records and files that comply with cGMP and ISO requirements such as Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF)


  • Minimum of 4 year technical degree (BS/ME preferred) or similar work experience required
  • Knowledge of DOE, FMEA and Risk Management processes preferred
  • Knowledge of Trigonometry, Geometry and Algebra required
  • Minimum 5 years work experience as a Product Designer utilizing design control procedures with medical devices (in an ISO certified company) required
  • Minimum 5 years experience with 2D and 3D solid modeling software (AutoCAD, SolidWorks) required
  • Experience writing documentation supporting the Quality Systems, WI, forms, etc., in an ISO certified medical device company required
  • Knowledge of manufacturing assembly, Quality Assurance, machine shop, plastics, metals, and materials preferred

Post Date: 06.07.2019

Salary: Dependent on Qualifications

Shift: 1st

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If you would prefer to speak directly to an Inginaire Staffing Consultant, please call us at 612-977-1450 and reference OrderID 816281

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Would you like an opportunity to work for some of the most renowned engineering companies in the Midwest? If you have the job skills, a proven work history, and are energized to start something new, our friendly staffing team is eager to guide you through the application and screening process, and make something awesome together. With unique employee benefits, job training programs, zero registration fees, and above-and-beyond personalized service – you’ll wonder why we haven’t partnered sooner! Get in touch with us to get the ball rolling.

Inginaire is an Equal Opportunity Employer.