Principal Engineer

Sustaining R&D Engineer – Medical DevicesHelp 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 DoLead 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 ForBS 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 moldingExtrusionUltrasonic weldingUV/solvent bondingSterilization processesDeep 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 QualificationsProject 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 benefitsIf 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 processWorkplace Type: This is a hybrid position in Plymouth,MN.Application Deadline: This position is anticipated to close on Aug 21, 2026.