Principal Engineer

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.
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Responsibilities

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

Job Description

Sustaining R&D Engineer - Medical Devices

Help drive innovation in life-sustaining medical technologies. Join a global leader in vital organ therapies and play a key role in advancing products that improve outcomes for patients worldwide. As a Sustaining R&D Engineer, you’ll lead design changes, product improvements, and engineering initiatives for Class II and III disposable medical devices while collaborating with global teams to enhance quality, performance, and patient experience.

What You’ll Do

• Lead the design and development of product improvements and sustaining engineering initiatives for disposable medical devices.
• Manage engineering projects from concept through implementation, including timelines, budgets, and deliverables.
• Serve as the technical expert on design changes involving materials, suppliers, labeling, CAPA/NCR activities, remediation efforts, and cost reduction projects.
• Investigate and resolve complex technical challenges using risk-based engineering principles and customer-focused solutions.
• Apply engineering tools such as dFMEA, Human Factors Engineering, statistical analysis, and CAD to support product improvements.
• Lead the creation, maintenance, and compliance of Design History Files (DHF).
• Partner with global cross-functional teams across R&D, Quality, Manufacturing, Regulatory, and Supply Chain.
• Ensure compliance with FDA Design Controls, ISO standards, and international regulatory requirements.
• Mentor engineers and technicians while contributing to innovation initiatives, patent disclosures, and intellectual property development.

What We’re Looking For

• BS in Mechanical, Plastics, Biomedical Engineering, or a related field (MS preferred).
• 5+ years of medical device development experience, preferably with Class II or Class III disposable products.
• Strong expertise in plastics materials and manufacturing processes, including:
  • Injection molding
  • Extrusion
  • Ultrasonic welding
  • UV/solvent bonding
  • Sterilization processes
• Deep understanding of FDA Design Controls and ISO Quality Management Systems.
• Experience with CAD and PDM software such as Creo or SolidWorks.
• Knowledge of medical device risk management standards and methodologies.
• Strong technical problem-solving, project leadership, and communication skills.

Preferred Qualifications

• Project management experience leading cross-functional engineering initiatives.
• Experience supporting CAPA, NCR, remediation, and product lifecycle management activities.
• Ability to coach, mentor, and develop junior engineers and technical team members.
• Passion for continuous improvement, innovation, and implementing best practices.
• Experience with Human Factors Engineering and risk management tools such as dFMEA.

Why Join Us?

• Work for a global healthcare leader with a 70-year legacy of innovation.
• Make a direct impact on therapies that help patients live longer, healthier lives.
• Lead meaningful engineering projects with global visibility and influence.
• Collaborate with talented teams across R&D, Quality, Manufacturing, and Regulatory functions.
• Competitive compensation and benefits

If you’re passionate about medical device innovation, enjoy solving complex engineering challenges, and want to improve patient lives on a global scale, we’d love to hear from you.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $104000.00 - $156000.00/yr.

Benefits to be provided once in process

Workplace Type

This is a hybrid position in Plymouth,MN.

Application Deadline

This position is anticipated to close on Aug 21, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.