Product Development Engineer

A client of ours is seeking a Product Development Engineer with MEDICAL DEVICE experience to join their team and work along the development process anywhere from concept and ideation through commercialization. Targeting entry to mid level medical device engineers. This is a direct hire opening located in Maple Grove, MN.

Duties and Responsibilities

• Leads development of concepts, prototypes, processes, and products from initial design to market release
• Assists in writing proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts
• Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation
• Maintains detailed documentation throughout all phases of research and development
• Ability to generate and execute protocols and reports as needed to support validation activities, including Design Verification, IQ, OQ, PQ

Position Qualifications:

• Bachelor's degree in Mechanical, or Biomedical Engineering is preferred
• Seeking candidates with 1 to 5 years of experience within medical device design and development
• Familiarity with FDA QSR and ISO 13485 medical device regulations
• SolidWorks 3D CAD proficiency
• Familiarity with design for catheters and extrusions is highly preferred but not required