Program Manager - Medical Device - Billerica, MA

As the Program Manager, you will leads cross‑functional teams to deliver innovative, software‑enabled electromechanical medical device products through the full development lifecycle. It offers the opportunity to drive complex programs, influence strategic decisions, and help bring life changing technologies to market

Client Details

My client is a fast growing, innovation driven organization operating at the intersection of engineering, healthcare, and advanced technology. They are known for developing sophisticated medical device systems that combine capital equipment, disposable components, and embedded software to meet critical clinical needs.

The organization fosters a collaborative, mission focused culture where technical excellence, quality, and regulatory rigor are essential to success. Employees are empowered to take ownership, continuously improve processes, and make meaningful contributions that directly impact patients and clinicians worldwide.

Description

Reporting directly into the Director of Engineering, you will be responsible for the following:

• Lead end‑to‑end execution of new product development programs involving complex medical device systems
• Build and manage detailed program plans covering scope, timelines, budgets, and resourcing
• Create and maintain integrated schedules, including Gantt charts and work breakdown structures, while actively managing critical paths and risks
• Coordinate and align cross‑functional teams across R&D, Quality, Regulatory, Clinical, Operations, and Commercial functions
• Manage integration points and dependencies between hardware, disposable, and software development streams
• Oversee design control activities to ensure documentation, traceability, and regulatory readiness
• Manage external partners and vendors, including contract manufacturers, software providers, and testing suppliers
• Act as the primary communication lead for program status, risks, and decisions with stakeholders and leadership
• Facilitate phase‑gate reviews and ensure deliverables meet quality and regulatory expectations
• Track program metrics, escalate issues, and drive timely resolution
• Coach and mentor team members on best practices in program and project management
• Identify and implement process improvements to enhance delivery efficiency and consistency

Profile

• Education: Bachelor's degree in engineering, life sciences, or a related technical discipline; advanced degree preferred
• Significant experience leading programs or projects within medical device or relevant regulated industries
• Demonstrated success managing full product lifecycles, including design controls and regulatory submissions
• Strong understanding of quality systems and global regulatory requirements (e.g., FDA, ISO standards)
• Proven ability to lead cross‑functional teams and manage multiple priorities in a fast paced environment
• Excellent communication, organizational, and stakeholder management skills
• Excellent presentation skills
• Hands‑on experience using project management tools
• PMP or similar certification is an advantage
• Experience with higher risk medical devices, system level integration, or hardware/software platforms is highly desirable

Job Offer

• Competitive salary and comprehensive benefits package
• Opportunity to work on cutting edge medical technologies with real patient impact
• High visibility role with exposure to senior leadership and strategic programs
• Professional development through challenging programs, mentorship, and continuous improvement initiatives
• Collaborative and mission driven culture that values ownership, quality, and innovation
• Stable yet fast growing environment offering long term career progression

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.