Medical Device Systems Engineer

• 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
• Hands-on experience with Use-Related Risk Analysis (URRA), Human Factors, or Risk Management.
• Strong experience with Design Controls and Design History File (DHF) documentation in a regulated environment.
• Experience working in a cross-functional, matrixed organization with strong communication and facilitation skills.

• Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned medical device and combination product programs.
• Facilitate cross-functional meetings and collaborate with Human Factors, Quality, Clinical, Medical Safety, Development, and Manufacturing teams to identify hazards, use errors, risks, and mitigations.
• Support key systems engineering activities, including system architecture, user needs, product requirements, traceability, risk management, and change management.
• Develop and maintain Design Control documentation and Design History Files (DHF) in accordance with applicable regulations and internal procedures.
• Support risk assessments, including URRA, Design FMEA, and Process FMEA activities.
• Monitor project schedules, milestones, risks, and deliverables; escalate issues and delays as needed.
• Support integration of third-party development activities, including vendor communications and deliverable reviews.
• Drive consistent execution of systems engineering and risk management processes and identify opportunities for improvement.

• BS in Engineering, Science, or a related technical discipline with 5+ years of relevant experience, or MS with 3+ years of experience.
• 3–5 years of experience in pharmaceutical, medical device, combination product, or another regulated industry.
• Experience with Use-Related Risk Analysis, Human Factors, Risk Management, and/or product development.
• Strong experience with Design Controls and Design History File (DHF) management.
• Working knowledge of systems engineering principles, including requirements definition, traceability, risk management, product architecture, and change management.
• Experience with applicable regulatory standards such as FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, or EU MDR.
• Strong organizational, facilitation, communication, and analytical skills.
• Ability to influence cross-functional teams, manage competing priorities, and work effectively in a highly matrixed environment.
• Experience with project tracking/document management tools and third-party vendor coordination preferred.
• Experience supporting drug delivery systems, medical devices, or combination products preferred.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.