Medical Device Product Development Engineer

Midwest Interventional Systems Inc; Maple Grove (MN); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Health, Dental, and Vision coverage

HSA with employer contribution

401(k) with employer contribution

Job summary

Midwest Interventional Systems Inc in Maple Grove, MN seeks a Product Development Engineer I to drive design transfer, testing, risk management, and documentation for medical devices under QMSR, ISO 13485:2016, and ISO 14971. You will support design transfer activities, develop and validate test methods, and maintain traceability across development stages.

The role requires 0–3 years in medical device design, SolidWorks proficiency, and experience with Minitab.

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering (or related field).
• 0–3 years of experience in medical device design under design controls.
• Working knowledge of 21 CFR 820/QMSR, ISO 13485:2016, and ISO 14971.
• Proficiency in SolidWorks; experience with GD&T and tolerance stack-ups.
• Hands-on prototyping, testing, fixture development, and measurement skills.
• Experience with Minitab for statistics, DOE, and gage R&R.
• Preferred: Experience with catheter technologies and relevant anatomy.

Responsibilities

• Support design transfer activities including DFM/DFA input, pilot builds, process development, and required documentation.
• Develop and validate test methods; design simple fixtures to enable repeatable testing.
• Maintain requirements traceability and contribute to formal design reviews.
• Execute verification protocols, analyze data, and generate compliant reports.
• Perform feasibility studies, product characterization, and risk analysis.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and suppliers.
• Participate in customer meetings and present technical updates as needed.
• Maintain accurate engineering documentation throughout all development phases.

Skills

Hands-on prototyping

Testing

Team collaboration

Documentation

Education

Bachelor’s degree in Mechanical or Biomedical Engineering

Tools

SolidWorks

GD&T

Tolerance stack-ups

Minitab

Job description

Midwest Interventional Systems Inc in Maple Grove, MN seeks a Product Development Engineer I to drive design transfer, testing, risk management, and documentation for medical devices under QMSR, ISO 13485:2016, and ISO 14971. You will support design transfer activities, develop and validate test methods, and maintain traceability across development stages.

The role requires 0–3 years in medical device design, SolidWorks proficiency, and experience with Minitab.