Program Manager - Medical Device - Wakefield, MA

About Our Client

My client is a world leader for Class III medical devices. This is an exciting time to join the company as they are growing considerably right now and are working on expanding their product lines!

Job Description

The Program Manager will:

• Lead end‑to‑end execution of complex new product development programs spanning capital equipment, disposable components, and software‑enabled systems
• Develop and manage comprehensive program plans, including scope, schedules, budgets, resources, and risk management strategies
• Create and maintain detailed program schedules (Gantt charts, WBS), identify critical paths and interdependencies, and proactively mitigate timeline risks
• Coordinate cross‑functional teams across R&D, Quality, Regulatory, Clinical, Operations, and Commercial to achieve program objectives
• Manage integration and dependencies across hardware, disposable, and software development workstreams to ensure aligned execution
• Oversee design control activities, ensuring documentation completeness, traceability, and regulatory readiness
• Manage external vendor and partner relationships, including software providers, contract manufacturers, and testing partners
• Serve as the primary point of contact for program communication, delivering clear status updates to senior leadership and key stakeholders
• Facilitate phase‑gate reviews and ensure deliverables meet quality system and regulatory requirements
• Track and report program metrics, proactively escalate risks or issues, and drive timely resolution

Apply today for immediate consideration!

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The successful Program Manager will have the following qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field, MAster's degree of MBA is prefered
• 5+ years of program or project management experience within the medical device, biotech, or pharmaceutical industry
• Demonstrated experience managing full product lifecycle programs, including design controls and regulatory submissions
• Proven ability to lead cross‑functional teams and deliver FDA‑regulated products
• Strong working knowledge of quality systems and regulatory requirements (FDA, ISO, EU MDR, etc.)
• Experience supporting Class II or Class III medical devices
• Background in systems engineering or integration of hardware and software platforms
• Familiarity with clinical trial planning and execution
• Working knowledge of risk management (ISO 14971), usability engineering, and design verification/validation (V&V)
• What's on Offer
• Competitive compensation
• Comprehensive benefits package
• 401K with company match
• Full health insurance including medical, dental and vision
• Generous PTO
• 11 paid holidays
• Great company culture and room for growth!