Senior Program Manager, Medical Device Development

Nova Biomedical Corporation; Waltham (MA); On-site; USD 190,000 - 270,000; Full time

Benefits offered by this job

Competitive 401k company match

Bonus program, generous PTO and paidH

Job summary

Nova Biomedical in Waltham, MA is seeking a Program Manager to own end-to-end execution of new product development and sustaining programs, from proposal through launch and post-launch surveillance. This role is the single point of accountability for program delivery across R&D, Quality, Regulatory, Operations, and more.

The ideal candidate holds a Bachelor's in engineering or life sciences, 7+ years in product development/program management, and experience with stage-gate medical device

Qualifications

• Bachelor's degree in engineering, life sciences, or related technical discipline.
• 7+ years in product development, program or project management, including 3+ years leading cross-functional programs end to end.
• 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

• End-to-End Program Ownership: Own the integrated program plan covering scope, schedule, resources, deliverables, dependencies, and critical path across all stages.
• Stage Gate Governance: Manage projects through Nova's stage gate process with complete deliverables and evidence at each gate.
• Sustaining and Lifecycle Programs: Manage post-release design changes, reliability and cost-down initiatives, and cross-product changes.
• Quality, Design Control and Regulatory Readiness: Ensure quality and compliance by design and maintain DHF index completeness.
• Risk, Issue and Dependency Management: Maintain the program risk register and manage dependencies across programs.
• Cross-Functional Leadership: Lead without direct authority and drive execution discipline and portfolio visibility.

Skills

Program management

Cross-functional leadership

Stage gate governance

Budget & forecasting

Regulatory awareness

Risk management

Education

Bachelor's degree in engineering or life sciences

Job description

Nova Biomedical in Waltham, MA is seeking a Program Manager to own end-to-end execution of new product development and sustaining programs, from proposal through launch and post-launch surveillance. This role is the single point of accountability for program delivery across R&D, Quality, Regulatory, Operations, and more.

The ideal candidate holds a Bachelor's in engineering or life sciences, 7+ years in product development/program management, and experience with stage-gate medical device