Inginaire - Engineering Staffing

Product Design Engineer

7 days left

Location
St Paul, MN
Salary
Contact For Rate
Posted
Dec 07, 2018
Closes
Dec 20, 2018
Ref
816281-03
Category
Engineering
Job Type
Employee
Employment Status
Full Time
Product Design EngineerInginaire 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.

Duties

  • 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)

Requirements

  • 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

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