R&D Engineer

Job Title: R&D Engineer
Location: Minnetonka, MN 55345
Duration: 12 Months
Work Mode: Onsite 5 days/week
Shift: 8:00 AM 5:00 PM

We are seeking an R&D Engineer with a strong focus on Process Development to support medical device manufacturing and catheter delivery system projects.

• Support process validation activities including IQ, OQ, and PQ
  .
• Support equipment design and development.
• Develop manufacturing procedures, technical reports, and SOP documentation.
• Support DOE, process characterization, and engineering data analysis.
• Collaborate with R&D, Quality, Manufacturing Engineering, and Operations teams.
• Support assembly, UV curing, and mechanical assembly processes.

• 1 3 years of relevant experience
• Process Development experience or academic exposure.
• Understanding of IQ/OQ/PQ process validation
  .
• Strong technical writing and documentation skills.
• Strong communication and cross-functional collaboration skills.
• Self-driven and proactive approach.

• Mechanical or Biomedical Engineering background.
• CAD experience.
• Minitab/statistical analysis.
• Design of Experiments (DOE).
• Process characterization and data analysis.
• Medical device or catheter experience.
• R&D/Product Development experience.