Principal Engineer

About the role

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.

Responsibilities

• 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.
• Manage 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.

Requirements

• 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.

Benefits

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