Principal Program Manager

Nova Biomedical • Waltham, MA

20h • Onsite

About The Position

The Principal Program Manager owns end-to-end execution of assigned new product development and product-sustaining programs, from project proposal through commercial launch and post-launch surveillance. This role is the single point of accountability for program delivery, maintaining an integrated plan, committed dates, and a credible view of program status. Product Management owns Voice of Customer, market requirements definition, and the NPV/business case; the Program Manager ensures functional leaders deliver stage-gate commitments on time, to the required quality, and in the right sequence. Success is measured by milestone achievement and gate readiness across the portfolio.

The role manages the integrated program plan, milestones, operating cadence, status reporting, budget, and stage-gate governance. It leads sustaining and lifecycle programs, including post-release design changes, reliability and cost-down initiatives, component obsolescence, field-derived work, and product end-of-life planning. The Program Manager ensures quality, design-control, documentation, and regulatory readiness; actively manages risks, issues, and dependencies; and leads cross-functional teams without direct authority. The role also improves program-management practices and provides leadership with visibility into program health, capacity constraints, trade-offs, and prioritization recommendations.

Requirements

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• At least 7 years of experience in product development, program management, or project management.
• At least 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 new product development and sustaining/lifecycle programs, including design changes and field corrective actions, and managing change implementation 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 tools, schedule and critical-path management, and executive-level status reporting.
• Ability to work at a computer for extended periods.
• Ability to lift and carry up to 25–50 pounds as required.
• Ability to communicate effectively by phone, video, and in writing.
• Ability to occasionally move about the office to access meetings or resources.

Nice To Haves

• PMP, PgMP, or equivalent program-management certification.
• Experience with instrumentation, consumables, and software combination programs.
• Experience managing a portfolio of concurrent programs with shared resources.
• Exposure to design transfer, process validation, and manufacturing scale-up.

Responsibilities

• Own and maintain an integrated cross-functional program plan covering scope, schedule, resources, deliverables, dependencies, and critical path across the product lifecycle.
• Manage programs through the stage-gate process from inception through launch and post-launch surveillance.
• Hold functional representatives accountable for committed deliverables and dates; identify slippage, facilitate trade-offs, and drive recovery plans with named owners and dates.
• Align leadership on milestones and timelines; lead core-team meetings, drive decisions to closure, document commitments, and escalate blockers.
• Maintain program status reporting for core teams, leadership, and portfolio reviews, including schedule health, risks, issues, dependencies, and decisions required.
• Develop and manage program budgets, track actuals and forecasts, and identify cost-saving opportunities.
• Prepare and lead gate reviews, assemble gate packages, confirm deliverable completeness, surface risks and exceptions, and secure documented approval to progress.
• Ensure tailoring of deliverables is justified, documented, and approved.
• Manage sustaining programs, including post-release design changes, reliability and cost-down initiatives, component obsolescence, and cross-product changes.
• Translate complaints, CAPA, service data, and post-market surveillance findings into prioritized, scheduled, resourced sustaining work with clear ownership.
• Coordinate product end-of-life and transition planning across regulatory, service, spare-parts, labeling, and customer-communication obligations.
• Execute programs in accordance with design and development procedures, design controls, risk management, software lifecycle and cybersecurity requirements, and applicable regulations.
• Drive Design History File (DHF) index completeness and audit readiness throughout the program, keeping records current at each gate.
• Partner with Quality and Regulatory to align documentation, classification, submission timing, and evidence requirements with program schedules and target markets.
• Maintain program risk registers covering technical, supply, regulatory, resource, and launch risks, including mitigation and contingency plans.
• Identify cross-program and intra-program dependencies, shared resources, shared platform elements, and sequencing conflicts; escalate resource contention with options and impact.
• Escalate issues with a clear problem statement, options, impact, and recommended path.
• Lead peers and senior functional leaders without direct authority, resolving conflict and holding cross-functional representatives accountable.
• Improve program-management practices, templates, metrics, and reporting standards, and coach functional leads and project managers on gate expectations.
• Provide leadership with visibility into program health, capacity constraints, trade-offs, and prioritization recommendations.

Benefits

• Flexible medical, dental, and vision coverage.
• Competitive 401(k) company match.
• Bonus program.
• Generous paid time off and paid holidays.
• Tuition reimbursement.
• Hybrid and flexible work arrangements.
• Professional development, engagement, and events.
• Company marketplace for lunch and snacks at the Norwood, MA; Billerica, MA; and Westbrook, ME offices.
• Company-subsidized cafeteria at the Waltham, MA office.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal