Sr Manager New Product Development

Job 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.

Program 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 

• 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