Project Manager II

Position Overview: Senior Program Manager – Combination Products & Medical Device Testing

This is a client-facing technical program leadership role responsible for managing multiple combination product and medical device testing programs simultaneously. The individual will serve as the primary point of contact for clients while coordinating laboratory testing, engineering, quality, and project management teams to ensure projects are delivered on time, within budget, and in compliance with regulatory requirements.

• Key Responsibilities Lead multiple concurrent combination product and medical device testing programs.
• Serve as the primary client contact and manage expectations, timelines, budgets, and deliverables.
• Coordinate cross-functional teams across Engineering, Laboratory Operations, Quality, and Project Management.
• Drive execution of testing activities including:
• Design Verification
• Characterization Testing
• Method Validation
• Engineering Investigations
• Complaint Testing
• Container Closure Integrity Testing (CCIT)
• Facilitate troubleshooting, risk mitigation, issue escalation, and schedule management.
• Support laboratory resource planning, equipment utilization, and testing prioritization.
• Provide technical leadership on device testing strategies, protocol development, data interpretation, and investigations.
• Maintain visibility into project risks, client priorities, and overall program health.

Ideal Candidate Background

• Education Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Life Sciences, or related technical discipline.
• Experience 5–10+ years within:
• Combination Products
• Medical Devices
• Device Testing & Verification
• Technical Program Management
• Product Development Engineering
• Technical Expertise Combination product testing and development.
• Device verification and validation activities.
• DHF (Design History File) support.
• Engineering investigations and root cause analysis.
• Laboratory testing operations.
• Medical device development lifecycle.
• Preferred Device Experience Autoinjectors
• Prefilled syringes
• Inhalers
• Wearable injectors
• Infusion pumps
• Vial access systems
• Regulatory Knowledge cGMP
• cGLP
• cGDP
• ISO standards
• Medical device quality systems and development practices

What Makes Someone a Strong Fit?

• The strongest candidates will likely come from organizations such as medical device manufacturers, combination product developers, testing laboratories, CDMOs, or consulting firms and have a blend of:Technical device testing expertise
• Client-facing project leadership
• Laboratory operations experience
• Cross-functional team management
• Combination product development knowledge

Key Search Titles

• When sourcing candidates, target titles such as:Senior Program Manager
• Technical Program Manager
• Combination Product Program Manager
• Medical Device Program Manager
• Engineering Program Manager
• Verification & Validation (V&V) Manager
• Product Development Manager
• R&D Program Manager
• Device Development Lead
• Technical Project Manager

This role appears to be approximately 60% program leadership/client management and 40% technical oversight of device testing activities , making combination product experience and the ability to communicate credibly with both clients and engineers critical.