Global Program Manager, Medical Devices

Nova Biomedical; Waltham (MA); On-site; USD 190,000 - 250,000; Full time

Job summary

Nova Biomedical in Waltham, MA is seeking a Program Manager to own end-to-end development programs from proposal through commercial launch and post-launch surveillance. You will coordinate with R&D, Regulatory, Quality, Operations, and Marketing to ensure milestones are met on time.

The role drives cross-functional accountability, manages the integrated program plan, and oversees budget and risk across the portfolio. A strong background in medical-device stage-gate processes is required.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• 7+ years in product development, program or project management, including 3+ years leading cross-functional programs end to end.
• Demonstrated ownership of at least one product program from concept through commercial launch in a regulated medical device, IVD, diagnostics, or life science instrumentation environment.
• Working fluency in stage gate medical device and/or diagnostic development, design controls, and risk management within an ISO 13485 / FDA QMSR quality system.
• Experience managing both new product development and sustaining/lifecycle programs, including design changes and field corrective actions across the global regulatory landscape.
• Proven ability to hold senior cross-functional leaders accountable to commitments without direct reporting authority.
• Strong command of program management tooling, schedule and critical path management, and executive-level status reporting.

Responsibilities

• Own the integrated program plan across all stages of the product lifecycle.
• Drive milestone accountability and ensure deliverables meet committed dates.
• Lead core team meetings and elevate blockers to leadership.
• Maintain program status reporting for core team and portfolio reviews.
• Develop and manage the program budget with forecasted cost performance.
• Enforce stage gate governance and ensure evidence is complete at each gate.

Skills

Program management

Cross-functional leadership

Risk management

Stakeholder management

Stage gate process

Education

Engineering degree

Tools

Project management tools

Job description

Nova Biomedical in Waltham, MA is seeking a Program Manager to own end-to-end development programs from proposal through commercial launch and post-launch surveillance. You will coordinate with R&D, Regulatory, Quality, Operations, and Marketing to ensure milestones are met on time.

The role drives cross-functional accountability, manages the integrated program plan, and oversees budget and risk across the portfolio. A strong background in medical-device stage-gate processes is required.