Program Manager Advanced Product Development

Primary Function of Position:

The Program Manager Advanced Product Development is a strategic leader within Intuitive Surgicals 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.

Roles & 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.

Qualifications :

Qualifications

Skills Experience Education & Training:

• Bachelors degree with 12 years of progressive experience or a Masters 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 have:

• 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.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time