Product Lifecycle Engineering Principal Scientist - Medical Device & Combination Products

Key Responsibilities

• Collaborate with highly cross-functional teams to Lead sustaining engineering activities for commercialized medical devices and drug delivery combination products.
• Maintain and update design history documentation, engineering records, and lifecycle deliverables in accordance with internal procedures and regulatory expectations.
• Ensure risk management documentation is current and aligned with post-market product changes, investigations, and ongoing commercialization needs.
• Support engineering assessments related to design changes, component updates, supplier changes, and product improvements.
• Partner with Quality Assurance, Regulatory Affairs, Process Development, Analytical, Labeling, and Manufacturing to assess product impact and implement lifecycle changes effectively.
• Evaluate technical issues arising during commercialization and post-market support, and drive timely resolution.
• Provide engineering input to change control, deviation investigations, CAPA, and nonconformance activities, as applicable.
• Support continued compliance with applicable design control, risk management, and medical device / combination product requirements.
• Contribute to product robustness, reliability, and manufacturability through data-driven engineering decisions.
• Participate in cross-functional reviews to ensure product lifecycle activities are appropriately documented and executed.
• Identify opportunities for continuous improvement in sustaining engineering processes, documentation practices, and cross-functional workflows.
• Serve as a technical resource for lifecycle management activities associated with commercial drug delivery systems.
• Support Regulatory activities including authoring regulatory submission documentation.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related scientific/engineering discipline.
• Minimum of 10 years of experience working within a regulated medical device, drug delivery, and combination product environment.
• Strong knowledge of design controls and risk management for regulated products.
• Demonstrated experience in sustaining engineering, product lifecycle management, or post-market design assurance in collaboration with cross-functional product support from Quality, Regulatory, and Manufacturing teams.
• Working knowledge of process engineering and manufacturing methods, analytical methods, labeling and packaging, and systems engineering.
• Strong technical writing, problem-solving, and communication skills.
• Able to manage multiple priorities and work effectively across teams.
• Experience supporting change assessments and design updates in a structured quality system.

Experience

• Experience with product development of combination products, specifically drug delivery systems.
• Experience with design controls and risk management as it pertains to FDA, EU MDR, and associated harmonized standards (ISO 13485, ISO 14971, 21CFR.820 and 21CFR Part 4).
• A thorough understanding of GxP principles and practices.

Pay Range

$145,600 - $218,400