Program Manager Systems

Primary Function of Position:

The Program is responsible for leading and executing the full product development lifecycle of medical device capital systems from initial concept through commercial launch. This role requires deep expertise in medical device development regulatory pathways operations and cross-functional project management. The Program Manager serves as a key driver of product innovation compliance and operational excellence within the organization. The Program Manager provides strategic leadership and tactical execution across all stages of product development including concept generation design prototyping verification and validation regulatory submissions manufacturing transfer and launch. The role is pivotal in ensuring that all products meet stringent compliance requirements including FDA EU MDR ISO standards and relevant quality system regulations.

Roles & Responsibilities:

Strategic Leadership

• Partner with product technical and functional leaders to shape program strategy roadmap priorities and execution plans.
• Align engineering clinical operations regulatory and product teams to meet program and portfolio goals.
• Facilitate program reviews and structured decisions to resolve issues balance trade-offs and maintain momentum.
• Lead cross-functional negotiations resolve root-cause disputes and build sustainable stakeholder alignment.
• Create concise executive narratives and reports that integrate analysis recommendations risks and trade-offs.

Product & Design Development

• Lead cross-functional teams through concept development design iteration prototyping verification/validation and design transfer to manufacturing.
• Resolve cross-functional dependencies across subsystem teams external partners manufacturing regulatory and commercial functions.
• Partner with design clinical human factors and engineering teams to ensure product requirements usability and performance criteria are met.
• Lead design control and business reviews ensuring governance compliance accountability and timely escalation.

Operational Execution

• Drive manufacturing readiness including process development supply chain coordination build readiness and launch planning.
• Ensure smooth transition from R&D to operations with strong cross-functional integration and documentation rigor.
• Support ongoing product lifecycle cost reductions reliability improvements and sustainment workstreams.
• Partner with Finance to monitor program budgets resource allocation and long-term financial impacts.
• Manage scope across projects evaluating strategic alignment delivery impact dependencies and trade-offs.
• Optimize WBS and program schedules across interdependent projects including critical and near-critical path analysis.

Regulatory & Compliance

• Ensure project deliverables meet relevant US and global medical device standards and quality system requirements.
• Coordinate cross-functional preparation of regulatory documentation and testing.
• Champion strong design controls risk management and audit-ready documentation throughout the lifecycle.
• Anticipate systemic regulatory financial operational and technical risks; drive cross-functional response plans.

Qualifications :

Skills Experience Education & Training:

Required:

• Bachelors degree in Mechanical Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• At least a minimum of 10 years experience leading complex medical device development programs including capital equipment or system-level products from concept through commercial launch.
• In-depth knowledge of medical device regulatory pathways (FDA EU MDR ISO 13485) submission requirements and quality system regulations.
• Proven ability to lead and influence cross-functional teams at multiple levels of the organization.
• Experience collaborating with engineering operations regulatory quality and clinical teams throughout all development phases.
• Exceptional communication and stakeholder-management skills.
• Ability to handle ambiguity effectively and oversee multiple large projects at once
• Advanced program planning skills including WBS dependency management critical path analysis scope control risk management and governance reporting.
• Ability to coach peers on stakeholder engagement communication scheduling discipline and program management tools.
• Experience evaluating trade-offs across product features customer needs manufacturability and cost.

Preferred:

• Experience in robotic surgery software/mechanical/electrical/optical technology based products and design transfer to manufacturing and service organizations.
• PMP certification or formal project management training.
• Familiarity with ALM/PLM systems Agile methodologies and project management tools.
• Start-up experience a plus.

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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process please contact People Services at

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