R&D Engineer

R&D Engineer

This position involves designing and developing innovative medical devices that provide comprehensive procedural solutions. The role requires collaboration with engineering staff to meet objectives for design, new product development, and improvement of existing product lines, adhering to FDA QSR (21 CFR 820) and the Quality Management System (QMS).

Responsibilities:

• Support the R&D team in designing and testing catheters and delivery systems.
• Develop concepts, designs, and details for machines, tools, and fixtures.
• Engage in overall design, design for manufacturing, test method development, and product verification and validation testing.
• Lead technical discussions and decision-making with cross-functional teams.
• Act as a liaison between external vendors and the core team.
• Develop specifications, engineering blueprints, and detailed drawings.
• Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Implement design changes for existing products and ensure proper documentation of changes.
• Create engineering designs, develop plans, and maintain laboratory notebooks on all work.
• Conduct testing (Bench, V&V, in vivo), develop and utilize test protocols, and generate written reports.
• Travel to customer sites, domestic and international, to gather VOC, perform testing, and troubleshoot activities.
• Conduct design reviews and pre-validation assessments to ensure safe and environmentally sound processes and designs.
• Oversee the purchase or design of equipment that meets health, safety, and environmental standards.

Essential

Skills:

• 5+ years of relevant engineering experience in medical device design, particularly catheter-focused.
• Expertise in product design/development and process development.
• Proficiency in CAD software such as AutoCAD or Solidworks.
• Knowledge in catheter design and development processes.
• Experience in documentation writing and statistical analysis.
• Understanding of Good Manufacturing Process and Good Documentation Practice.

Additional Skills &

Qualifications:

• Bachelor's Degree in Mechanical Engineering required.
• Master's Degree in Mechanical or Biomedical Engineering preferred.
• Experience with design of experiments (DOE) preferred.
• In-depth knowledge of materials and metals.

Job Type &

Location:

This is a Permanent position based out of Arden Hills, MN.

Pay and Benefits:

The pay range for this position is $125000.00 - $145000.00/yr.

- Comprehensive health/dental/vision - 401(k) with company match
- Paid time off (PTO) - Life/disability insurance
- Professional development like tuition reimbursement

Workplace Type:

This is a fully onsite position in Arden Hills, MN.

Final date to receive applications:

This position is anticipated to close on Jul 16, 2026.