Job DescriptionJob Summary
The Senior Manager, New Product Development is responsible for leading complex, cross-functional new product development programs from concept through commercialization. This role drives execution excellence across R&D, commercial, quality, and operations teams to ensure timely, compliant, and successful product launches. The position plays a critical role in aligning innovation with business strategy while reinforcing a high-performance, results-driven culture.
ResponsibilitiesProgram Leadership & Execution- Lead end-to-end new product development (NPD) programs from ideation through design, validation, understanding customer regulatory approval needs and product launch
- Establish and manage integrated program plans, timelines, budgets, and resource allocations
- Drive accountability across cross-functional teams to meet key milestones and deliverables
- Identify, assess, and mitigate program risks; escalate issues proactively to senior leadership
- Partner closely with R&D, Marketing, Quality, Operations and Supply Chain to ensure alignment and execution
- Lead core team meetings and governance forums; ensure clear decision-making and communication
- Coordinate design transfer to manufacturing and support scale-up activities
- Coordinate phase gate review meetings according to Zeus NPD phase gate process to ensure all deliverables are met.
- Ensure adherence to design control requirements, including FDA and ISO standards (e.g., design inputs/outputs, verification, validation)
- Partner with Quality to support any submissions and approvals where applicable
- Drive New Product Introduction (NPI) and commercialization readiness activities
- Align launch timelines with commercial strategy and market needs
- Ensure successful product transfer, supply readiness, and support post-launch monitoring working with marketing.
- Provide regular program updates to executive leadership, including status, risks, and financials
- Develop and present business cases, project charters, and stage-gate deliverables
- Ensure strong governance through stage-gate or phase review processes
- Champion best practices in program management, including stage-gate, Agile (where applicable), and lean methodologies
- Drive lessons learned and continuous improvement initiatives across the NPD lifecycle
Cross-Functional Collaboration- Partner closely with R&D, Marketing, Quality, Operations and Supply Chain to ensure alignment and execution
- Lead core team meetings and governance forums; ensure clear decision-making and communication
- Coordinate design transfer to manufacturing and support scale-up activities
- Coordinate phase gate review meetings according to Zeus NPD phase gate process to ensure all deliverables are met.
Regulatory & Compliance- Ensure adherence to design control requirements, including FDA and ISO standards (e.g., design inputs/outputs, verification, validation)
- Partner with Quality to support any submissions and approvals where applicable
Product Launch & Commercialization- Drive New Product Introduction (NPI) and commercialization readiness activities
- Align launch timelines with commercial strategy and market needs
- Ensure successful product transfer, supply readiness, and support post-launch monitoring working with marketing.
Stakeholder Communication & Governance- Provide regular program updates to executive leadership, including status, risks, and financials
- Develop and present business cases, project charters, and stage-gate deliverables
- Ensure strong governance through stage-gate or phase review processes
Continuous Improvement- Champion best practices in program management, including stage-gate, Agile (where applicable), and lean methodologies
- Drive lessons learned and continuous improvement initiatives across the NPD lifecycle
Qualifications- Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred)
- Minimum of 8 years of experience in product development and within medical devices or regulated industries
- 5+ years of program/project management experience leading complex, cross-functional initiatives
- Proven track record of successful product launches
- Deep understanding of medical device development processes, including design controls and regulatory pathways
- Strong leadership and influencing skills in a matrixed organization
- Excellent project management capabilities (planning, risk management, budgeting)
- Exceptional communication and executive presence
- Ability to operate in a fast-paced, high-performance environment
- PMP, PgMP, or equivalent certification
- Experience with FDA regulations, ISO 13485, and global regulatory requirements
- Familiarity with Agile or hybrid product development methodologies
- Drives execution with urgency and accountability
- Balances strategic thinking with operational excellence
- Builds strong partnerships and aligns diverse stakeholders
- Anticipates risks and navigates complexity effectively
Skills & Competencies- Deep understanding of medical device development processes, including design controls and regulatory pathways
- Strong leadership and influencing skills in a matrixed organization
- Excellent project management capabilities (planning, risk management, budgeting)
- Exceptional communication and executive presence
- Ability to operate in a fast-paced, high-performance environment
Preferred- PMP, PgMP, or equivalent certification
- Experience with FDA regulations, ISO 13485, and global regulatory requirements
- Familiarity with Agile or hybrid product development methodologies
Success Profile- Drives execution with urgency and accountability
- Balances strategic thinking with operational excellence
- Builds strong partnerships and aligns diverse stakeholders
- Anticipates risks and navigates complexity effectively
- Delivers high-quality products that meet customer and regulatory expectations
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