Senior Medical Device R&D Engineer (Hybrid, MN)

Actalent; Plymouth (MN); Hybrid; USD 88,000 - 121,000; Full time

Job summary

Actalent, Plymouth, MN, is seeking an engineering professional to support design changes for Class II/III disposable medical devices in a sustaining engineering environment. The role emphasizes product performance, regulatory compliance, and life-saving kidney care therapies.

The candidate will lead change management, perform testing/verification, and collaborate across functions to meet FDA/ISO standards while driving continuous improvement.

Qualifications

• Bachelor's degree in Mechanical, Plastics, Biomedical Engineering or 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 FDA Design Controls, ISO quality systems, and medical device risk management.

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/SolidWorks) 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.

Skills

Problem solving

Communication

Project management

Education

Bachelor's degree in Mechanical/Biomedical/Plastics Engineering

Master's degree in Engineering

Tools

Creo

SolidWorks

Job description

Actalent, Plymouth, MN, is seeking an engineering professional to support design changes for Class II/III disposable medical devices in a sustaining engineering environment. The role emphasizes product performance, regulatory compliance, and life-saving kidney care therapies.

The candidate will lead change management, perform testing/verification, and collaborate across functions to meet FDA/ISO standards while driving continuous improvement.