Senior R&D Engineer – Medical Devices (Hybrid)

Actalent; United States; Hybrid; USD 88,000 - 121,000; Full time

Job summary

Actalent in Plymouth, MN seeks a Mechanical/Biomedical Engineer to support design changes and sustaining engineering for Class II/III disposable medical devices, focusing on performance, regulatory compliance, and life-saving therapies.

You will lead design changes, develop tests, maintain design documentation, apply risk management and dfMEA, and collaborate across functions to meet FDA/ISO requirements and drive continuous improvement.

Qualifications

• Bachelor's degree in Mechanical, Plastics or Biomedical Engineering.
• 3+ years of experience developing or supporting Class II/III disposable medical devices.
• Experience with sustaining engineering and product change management.

Responsibilities

• Lead and support design changes for disposable medical devices, including materials, suppliers, labeling, CAPA, and cost reduction.
• Develop and execute test methods, product testing, and verification/validation activities.
• Create and maintain design documents, 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 within R&D and sustaining engineering.

Skills

CAD tools

Risk management

Statistical analysis

Project management

Communication

Cross-functional collaboration

Education

Bachelor's degree in Mechanical/Plastics/Biomedical Engineering

Tools

Creo

SolidWorks

Job description

Actalent in Plymouth, MN seeks a Mechanical/Biomedical Engineer to support design changes and sustaining engineering for Class II/III disposable medical devices, focusing on performance, regulatory compliance, and life-saving therapies.

You will lead design changes, develop tests, maintain design documentation, apply risk management and dfMEA, and collaborate across functions to meet FDA/ISO requirements and drive continuous improvement.