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. 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 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