Project Systems Engineer

Seeking a Project Engineer II / Systems Engineer to support the development of pharmaceutical delivery devices and combination products within a regulated R&D environment. The role will primarily focus on Use-Related Risk Analysis (URRA), Design Controls, DHF management, risk management, requirements, traceability, and systems integration across clinical and commercial development programs.

The ideal candidate will have 3 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated industries, with strong knowledge of human factors, risk management, FDA regulations, and Design Control processes.

Key Responsibilities

• Lead and coordinate Use-Related Risk Analysis (URRA) activities across assigned programs.
• Facilitate cross-functional reviews involving Human Factors, Quality, Clinical, Medical Safety, Engineering, Manufacturing, and Development teams.
• Identify and document hazards, use scenarios, use errors, failure modes, risks, and mitigations.
• Manage and maintain Design History File (DHF) documentation and Design Control deliverables.
• Support user needs, stakeholder requirements, product requirements, system architecture, and traceability activities.
• Develop and support risk management plans, system risk assessments, URRA, DFMEA, and PFMEA activities.
• Ensure compliance with applicable FDA and international regulatory requirements.
• Track project milestones, risks, issues, dependencies, and mitigation actions.
• Support change management, configuration management, systems integration, and third-party development activities.
• Collaborate with vendors on deliverables, technical reviews, acceptance testing, and project execution.
• Ensure project documentation is complete, consistent, audit-ready, and inspection-ready.

Skills Required

Must-Have

• 3 5+ years of experience in pharmaceutical, medical device, combination product, or other regulated environments.
• Hands-on experience with URRA / Use-Related Risk Analysis.
• Strong DHF and Design Control experience.
• Knowledge of Systems Engineering and product development lifecycle.
• Experience with requirements definition, traceability, risk management, and change management.
• Working knowledge of Human Factors and use-related risk management.
• Strong cross-functional facilitation, communication, and stakeholder management skills.
• Experience managing project schedules, risks, milestones, and deliverables.

Regulatory / Technical Knowledge

• FDA 21 CFR Part 820.30
• 21 CFR Part 4
• ISO 14971
• ISO 13485
• EU MDR
• Design Controls
• Risk Management
• Human Factors
• DHF Management
• Design Verification / Validation
• FMEA
• Requirements & Traceability

Preferred

• Experience with drug-delivery systems or combination products.
• Experience with autoinjectors, pre-filled syringes, on-body delivery devices, mixing devices, or electromechanical pumps.
• Vendor/third-party development experience.
• Experience working in global, highly matrixed R&D organizations.
• Strong technical/scientific writing and documentation skills.