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.

Skills, Experience, Education, & Training:

Required:

• Bachelor’s 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.

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 employees
who 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 government’s 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 employee’s
start 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 candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s 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 [email protected].

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.