Intuitive · 4 days ago
Program Manager - Advanced Product Development
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$201K/yr - $289K/yr
9+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care, dedicated to transforming healthcare. The Program Manager – Advanced Product Development will drive the development of innovative surgical platforms, overseeing the full product lifecycle from concept to commercial launch, while ensuring alignment with business objectives and regulatory compliance.
Health CareManufacturingMedical Device
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
Qualification
Required
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
Preferred
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
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
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2026-01-23
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