Senior R&D Engineer

Medical Device Engineer

Support the design, development, and implementation of product changes for Class II and III disposable medical devices within a sustaining engineering environment. This role focuses on improving product performance, ensuring regulatory compliance, and driving continuous improvement in support of life-saving kidney care therapies.

Key Responsibilities

• Lead and support design changes for disposable medical devices, including new materials, suppliers, features, labeling updates, CAPA actions, and cost reduction initiatives.
• Develop and execute test methods, product testing, and verification/validation activities.
• Create and maintain design documentation, specifications, drawings, protocols, and reports.
• Apply risk management tools, dFMEA, Human Factors Engineering, and statistical analysis to solve engineering challenges.
• Design and build prototypes, tooling, fixtures, and test equipment as needed.
• Use CAD tools (Creo/Solid Works) to develop and maintain product designs.
• Collaborate with cross-functional teams to ensure projects are completed on time and in compliance with FDA and ISO requirements.
• Support continuous improvement initiatives and best practices within R&D and sustaining engineering.

Required Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering, or a related field.
• 3+ years of experience developing or supporting Class II/III disposable medical devices.
• Experience with sustaining engineering and product change management.
• Knowledge of plastics manufacturing processes, including injection molding, extrusion, bonding, and sterilization.
• Proficiency with CAD tools such as Creo or Solid Works.
• Understanding of FDA Design Controls, ISO quality systems, and medical device risk management.
• Strong problem-solving, communication, and project management skills.

Preferred Qualifications

• Master's degree in Engineering.
• DFSS training or certification.
• Advanced Solid Works experience.
• Experience with prototype development, validation testing, CAPA/NCR activities, and design history documentation.

Work Environment

Hybrid schedule (Tuesday, Thursday, Friday onsite) in a regulated medical device environment. Collaborate with global teams to develop innovative products that improve patient outcomes while ensuring quality, safety, and regulatory compliance.

Job Type & Location

This is a Permanent position based out of Plymouth, MN.

Pay and Benefits

The pay range for this position is $88000.00 - $121000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Will get benefits from customer when needed.

Workplace Type

This is a hybrid position in Plymouth, MN.

Final date to receive applications

This position is anticipated to close on Sep 6, 2026.