Principal Engineer

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, including:
• Annual bonus opportunity
• Annual merit increases
• 401(k) with company match
• Paid holidays and generous PTO
• Hybrid work flexibility

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 Jul 16, 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.