Program Manager - Advanced Product Development

Intuitive•Sunnyvale, CA

About The Position

The Program Manager – Advanced Product Development is a strategic leader within Intuitive Surgical's Future Forward BU, responsible for driving the end-to-end development of groundbreaking surgical platforms. This role oversees the full product lifecycle, leading complex, multi-phased programs from early concept development through pre-clinical studies, clinical trials, regulatory approvals and successful commercial launch. The Program Manager leverages deep project management experience, technical expertise, business acumen, and exceptional cross-functional leadership to deliver innovative solutions that define the future of surgical care.

Requirements

Bachelor’s degree with 12+ years of progressive experience or a Master’s degree with 9+ years in medical device product development, program & project management with a proven record of leading successful product launches in highly regulated environments.
Demonstrated expertise in cross-functional program management, technical problem-solving, and business strategy integration.
Strong knowledge of regulatory and quality standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971 and IEC 62304.
Experience with PMA, 510(k), De Novo, OUS submissions
Exceptional communication, leadership, and stakeholder management skills.

Nice To Haves

Advanced project management certification (PMP, PgMP, or equivalent).
Experience with commercial readiness planning, market launch execution, and post-market surveillance.
Proven ability to build consensus and drive results across diverse teams and global stakeholders.
Technical proficiency in medical device engineering, clinical development, and regulatory affairs, including hands-on experience with various types of regulatory submissions.
Demonstrated ability to enhance governance and design control processes while maintaining agility in a dynamic, innovation-driven environment.
Start-up medical device experience is highly desirable.

Responsibilities

Program Leadership: Direct and manage complex, large-scale, multi-phased product development programs, ensuring alignment with strategic business objectives and successful delivery of commercial-ready platforms for minimally invasive robotic surgery.
Lifecycle Oversight: Lead project teams through all phases of product development including concept generation, design, pre-clinical validation, clinical execution, regulatory submissions, and market introduction ensuring milestones are achieved on time and within budget.
Cross-Functional Coordination: Serve as the primary interface between R&D, engineering, clinical affairs, regulatory, operations, quality, human factors and product management teams; drive collaboration and decision making to integrate technical, clinical, and business requirements throughout the program lifecycle.
Business Strategy Integration: Translate strategic vision into actionable development roadmaps; set priorities, allocate resources, and develop comprehensive schedules and risk management plans to optimize program outcomes.
Regulatory & Quality Compliance: Support design control activities and submission of regulatory documents (e.g., EC, IDE, PMA, 510(k), De Novo, and OUS regional submissions), ensuring all product and study documentation meets internal and external standards, audit requirements, and global regulations. Experience with different types of regulatory submissions is highly desirable.
Product Launch Execution: Support commercial readiness activities, including product availability, inventory management, logistics, and post-market surveillance; ensure seamless transition from development to market introduction.
Risk Management: Identify and mitigate technical, regulatory, and operational risks through proactive planning, issue resolution, and continuous process improvement.
Stakeholder Engagement: Communicate program status, risks, and successes to executive leadership and key stakeholders; foster strong partnerships with internal and external collaborators.
Process Improvement: Add value by improving processes related to project management, governance and design controls, while balancing these enhancements within a lean, fast-paced innovation environment.
Mentorship: Mentor junior members of the PMO group by providing ongoing guidance; foster a culture of learning, collaboration, and high performance within the PMO team.