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Job Details


Mechanical Engineering


Product Design Engineer  Saint Paul, MN  Posted: 1/29/2019
Job Description

Job ID#:

15565

Job Category:

Mechanical Engineering

Position Type:

Direct Only


Konik PrimeStaff is partnering with a global medical device engineering and manufacturing company in St. Paul that is seeking to add a Product Design Engineer to their R&D team. In this critical role the candidate will be responsible for development of products utilized in medical procedures. This is an excellent, direct hire role with a well-established company.
 
Responsibilities
  • Develop product concepts in line with FDA & ISO Design Control procedure processes
  • Support new and re-designed products
  • Author test protocols and acceptance criteria such as Product Validation testing; perform and document tests for final approval
  • Research new product technologies
  • Prepare/review prototype drawings as requested; provide accurate and timely drawings for final approval
  • Define manufacturing protocols and material specifications
  • Develop project plans and GANTT charts
  • Design, develop, and document fixtures related to assembly and production
  • Assist quality control in defining inspection standards and criteria for product prior to shipping
  • Investigate product complaints and determine corrective action
  • Create formal documentation such as QSP/s, work instructions, inspection procedures, manufacturing procedures, forms, etc. for final approvals
  • Create and maintain records and files that conform to cGMP and ISO standards including Device Master Record (DMR), Device History File (DHF), Design History Record (DHR) and Technical Construction Files (TCF)
  • Additional tasks as required

 
Job Requirements

 

Qualifications:
  • Minimum of 4-year technical degree or similar work experience required; BS in Mechanical Engineering preferred
  • 5+ years of product design experience utilizing design control procedures in an ISO certified company
  • 5+ years of 2D and 3D solid modeling (AutoCAD and SolidWorks) required
  • 3+ years of experience on a product development team working with medical devices
  • Experience writing documentation supporting the Quality Systems, WI, forms, etc. in an ISO certified medical device company
  • Ability to use calipers, micrometers, gauge pins, and optical comparator
 
Konik PrimeStaff is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.
 
 Konik PrimeStaff has been a leader in the technical staffing industry for more than 40 years, providing the fastest and easiest link between employees and employers. Konik PrimeStaff has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.




 

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