Principal Sustaining Engineer, Medical Devices

Actalent; Minnesota; Hybrid; USD 104,000 - 156,000; Full time

Job summary

Actalent in Plymouth, MN is seeking a Sustaining R&D Engineer to drive innovation for disposable medical devices. Lead design changes, product improvements, and sustaining initiatives for Class II/III devices, collaborating with global teams to enhance quality and patient outcomes.

You will manage projects end-to-end, apply risk-based engineering, and ensure FDA Design Controls and ISO QMS compliance. Strong plastics processing, CAD skills, and mentoring ability are preferred.

Qualifications

• BS in Mechanical, Plastics, Biomedical Engineering or related field; MS preferred.
• ,

Responsibilities

• Lead design and development of product improvements and sustaining engineering initiatives for disposable medical devices.
• 1

Skills

5+ years medical device development

Injection molding

Extrusion

Ultrasonic welding

UV/solvent bonding

Sterilization processes

FDA Design Controls

ISO QMS

CAD/PLM (Creo/SolidWorks)

Risk management

Problem solving

Project leadership

Communication

Project management

CAPA/NCR remediation

Mentoring

Continuous improvement

Human Factors Engineering

dFMEA

Education

Bachelor's in Mechanical, Plastics, Biomedical Engineering or related field

MS preferred

Tools

Creo

SolidWorks

PDM tooling

Job description

Actalent in Plymouth, MN is seeking a Sustaining R&D Engineer to drive innovation for disposable medical devices. Lead design changes, product improvements, and sustaining initiatives for Class II/III devices, collaborating with global teams to enhance quality and patient outcomes.

You will manage projects end-to-end, apply risk-based engineering, and ensure FDA Design Controls and ISO QMS compliance. Strong plastics processing, CAD skills, and mentoring ability are preferred.