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Principal R&D Product Development Engineer

A top tier global medical device company located in Plymouth, MN is currently seeking a Principle Product Development Engineer to join their R&D engineering team.

General Job Overview:

The company has a team of bright and energised research and development engineers currently and the culture is one of innovation, collaboration and passion. This position will suit an individual who is seeking the next step into a leadership position but who also wants to maintain a hands on role. You will be working day in and day out on mecho-electrical products and other medical device subsets to influence and revolutionize the industry. The team is a very tight group knit of engineers who collaborate together to achieve their goals and overcome any obstacles.

As a research and development manager you would oversee the planning and completion of mechanical engineering products in regards to the development and design of manufacturing equipment to enhance product quality and productions productivity.

Responsibilities & Qualifications:

  • Provide Technical and Project Leadership within the Design Services Group. Lead projects from concept phase through verification and validation activities and through appropriate transfer to production activities.
  • Identify development needs and potentials of employees, take a hands on approach to improving their skills and expertise through training and product assignment.
  • Coordinate with team members, internal and external suppliers, and outside professionals to ensure project output meets user's needs.

Qualifications:

  • Interventional Experience specific to EP Devices, Catheters, and Guidewires
  • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization
  • US FDA QSR and ISO 13485 requirements for design
  • B.S. degree in Manufacturing Engineering, Mechanical Engineering or other related engineering discipline, or equivalent experience
  • 7 or more years of experience in R&D or process development
  • 3 or more years of medical device or other regulated FDA/QSR and ISO environment
  • 2 or more years of experience providing work direction to other engineers/technicians
  • Interview process for this position would involve telephone call with hiring manager and a final on site interview. If this is something that is interesting to you please send your resume or call me directly at 312-453-9077 and ask for Ben.

Sthree US is acting as an Employment Agency in relation to this vacancy.