Job Summary: The 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: one integrated plan, one set of committed dates, and one credible view of program status.
The Program Manager does not own Voice of Customer, market requirements definition, or the NPV/business case • those responsibilities sit with Product Management. Instead, this role ensures that every functional leader • R&D, Product Management, Quality, Regulatory, Operations, Supply Chain, Service, Marketing, and Commercial • delivers their 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, not by coordination activity.
Responsibilities: 1. End-to-End Program Ownership
- Own the integrated program plan. Build and maintain a single cross-functional plan covering scope, schedule, resources, deliverables, dependencies, and critical path across all stages of the product lifecycle. Manage the stage gate process from inception to launch.
- Drive milestone accountability. Hold each functional representative accountable to their committed deliverables and dates; identify slippage early, force the trade-off conversation, and drive recovery plans with named owners and dates. Ensure leadership alignment with key milestones and timelines.
- Run the operating cadence. Lead core team meetings, drive decisions to closure, document commitments, and escalate promptly to functional leadership when a decision or resource is blocking progress.
- Maintain a single source of truth. Own program status reporting for core team, leadership, and portfolio review • schedule health, risks, issues, dependencies, and decisions required.
- Budget Responsibility: Develop and manage the program budget; track actuals and forecast financial performance. Identify current and future cost-savings opportunities for the program.
2. Stage Gate Governance
Manage assigned projects through Nova's stage gate process, ensuring the required deliverables and evidence are complete and reviewed at each gate:
- Prepare and lead gate reviews. Assemble the gate package, confirm deliverable completeness with each function, surface open risks and exceptions, and secure documented approval to progress.
- Enforce tailoring with rigor. Where deliverables are tailored based on project classification, ensure the rationale is documented and approved • not assumed.
3. Sustaining and Lifecycle Programs
- Execute the sustaining portfolio. Manage post-release design changes, reliability and cost-down initiatives, component obsolescence and cross-product changes through implementation via the appropriate stage gated path.
- Close the loop from the field. Ensure complaints, CAPA, service data, and post-market surveillance findings are translated into prioritized, scheduled, and resourced sustaining work with clear ownership.
- Manage product end of life. Coordinate discontinuation and transition planning across regulatory, service, spare parts, labeling, and customer communication obligations.
4. Quality, Design Control and Regulatory Readiness
- Ensure quality and compliance by design. Execute programs in accordance with the design and development procedure, design controls, risk management, and software lifecycle/cybersecurity requirements and applicable regulations.
- Own documentation completeness. Drive DHF index completeness and audit readiness throughout the program; confirm records are current at each gate rather than reconstructed at the end.
- Partner with Quality and Regulatory. Align documentation level, classification, submission timing, and evidence requirements to the program schedule and target markets.
5. Risk, Issue and Dependency Management
- Manage risk actively. Maintain the program risk register covering technical, supply, regulatory, resource, and launch risks with mitigation and contingency plans.
- Own cross-program and intra-program dependencies. Identify shared resources, shared platform elements, and sequencing conflicts across programs; escalate resource contention to portfolio leadership with options and impact.
- Escalate with a recommendation. Bring leadership a clear problem statement, options, impact, and a recommended path • not status alone.
6. Cross-Functional Leadership
- Lead without direct authority. Set direction, resolve conflict, and hold peers, cross-functional representatives and senior functional leaders accountable to their commitments in a matrixed organization.
- Build execution discipline. Improve program management practices, templates, metrics, and reporting standards; coach functional leads and project managers on gate expectations.
- Inform portfolio decisions. Provide leadership with clear visibility into program health, capacity constraints, trade-offs, and prioritization recommendations.
Experience Requirements: - 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 actionsmanaging 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 tooling, schedule and critical path management, and executive-level status reporting.
Preferred
- 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.
Physical Requirements and Working Conditions: - 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 via phone, video, and written communication.
- Ability to occasionally move about the office to access meetings or resources.
Work Location: Onsite in Waltham, MA Targeted Salary Range: $190,000-270,000/year Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.
