R&D Engineer

generis Tek•Minnetonka, MN
•Onsite

About The Position

Seeking an R&D Engineer contractor with 1-3 years of experience and a Bachelor's degree. The role is primarily focused on Process Development, despite the R&D Engineer title. Work will be focused on catheter delivery systems, involving processes such as assembly operations, UV curing, and mechanical assembly processes.

Requirements

  • Bachelor's degree
  • 1-3 years of experience
  • Mechanical Engineering, Biomedical Engineering, Electrical and Software Engineering backgrounds may also be considered if the candidate is a strong fit.
  • Self-driven and proactive mindset
  • Willingness to take initiative, ask questions, support a variety of tasks, and work with minimal direction after training
  • Strong communication and collaboration skills

Nice To Haves

  • CAD software experience
  • Strong technical writing/documentation skills
  • Statistical analysis experience
  • Minitab experience
  • Medical device industry experience, including internships
  • Quality management/documentation systems experience (TrackWise, electronic lab notebooks, Master Control, etc.) is not required.
  • Recent graduates with internship experience
  • Candidates with master’s degrees if within max bill rate
  • R&D and Product Development backgrounds

Responsibilities

  • Process validations: IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
  • Equipment design and development
  • Technical writing: Manufacturing Procedures (MPs), Technical reports, SOP documentation
  • Design of Experiments (DOE)
  • Process characterization and data analysis
  • Cross-functional collaboration with R&D, Quality Engineering (QE), Manufacturing Engineering (ME), and Operations
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