
Senior Manager, Strategy & Operational Readiness
Required skills
- Manufacturing
- Quality
- Business
- medical device
- regulated environment
Nice to have
- New Product Development
- NPD
- validation design transfer
- people management
- leadership position
- Project Management
Role summary
The Senior Manager of New Product Development Strategy & Operational Readiness is a strategic leadership role within Advanced Operations, focused on governing operating systems and readiness mechanisms for successful strategy execution and launch across multiple business units in the Endoscopy Division. This role involves leading governance processes, operational readiness reviews, business performance management, and cross-functional partnerships. Key responsibilities include managing risks, driving accountability, and representing Advanced Operations in M&A activities, with a focus on process validation and design transfer within a regulated medical device environment.
The Senior Manager of New Product Development Strategy & Operational Readiness is a highly strategic divisional leadership role within Advanced Operations, serving as a key connector between the business, cross-functional partners, and senior leaders across the Endoscopy Division. This role shapes and governs the operating systems, business reviews, decision frameworks, and readiness mechanisms that enable successful strategy execution, launch readiness, operational performance, integration readiness, and accountability across four Business Units.
What You Will Do
- Lead governance processes that prioritize strategic initiatives, monitor execution, and support leadership decision-making across multiple business units.
- Direct operational readiness reviews for new product development programs, identifying risks, escalation needs, and readiness gaps before key launch milestones.
- Manage monthly business performance reviews, including development and tracking of operational, readiness, and program performance metrics.
- Partner with leaders across engineering, quality, operations, supply chain, finance, regulatory, and product development functions to drive execution, accountability, and continuous improvement.
- Lead operational due diligence and integration activities for acquisitions that impact product development, manufacturing, or commercialization programs.
- Represent Advanced Operations in divisional mergers and acquisition activities involving products, technologies, manufacturing operations, including risk assessment and integration planning.
- Serve as Division Process Owner for Process Validation and Design Transfer, leading governance, training, procedural improvements, audit readiness, and continuous improvement initiatives to ensure compliant, scalable, and effective execution across product launches and integration activities.
- Establish standardized processes, review cadences, escalation pathways, and performance measures that improve visibility and execution consistency.
- Present risks, trends, recommendations, and business performance updates to senior and executive leadership teams.
What You Will Need
Required Qualifications
- Bachelor's degree in Engineering, Manufacturing, Operations, Quality, Business, or a related field.
- Minimum 10 years of experience in medical device, engineering, operations, supply chain, program management, and/or related fields.
- Master's degree in Business, Engineer, Operations, or a related field and
- Experience leading initiatives involving multiple functions, stakeholders, or business units within a regulated environment.
Preferred Qualifications
- Master's degree in Business, Engineering, Operations, or a related field.
- 5 or more years of experience in New Product Development (NPD), validation design transfer activities
- Experience in people management or holding a leadership position
- Certification(s) in Project Management, LEAN, Six Sigma, and/or related.
- Experience supporting mergers and acquisitions, operational integration, technology transfer, or large-scale business transformation initiatives.
- Experience with highly regulated environment, such as medical device or biotechnology.
United States of America Pay Ranges:
- Puerto Rico: $118,000 - $196,700 USD Annual
- USN: $135,600 - $225,900 USD Annual
- US5: $142,400 - $237,200 USD Annual
- US10: $149,200 - $248,500 USD Annual
- US15: $155,900 - $259,800 USD Annual
- US20: $162,700 - $271,100 USD Annual
- US30: $176,300 - $293,700 USD Annual
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