Senior Project Manager - Instruments & Accessories

Primary Function of Position:

The Senior Project Manager – Instruments & Accessories is responsible for leading and executing the full product development lifecycle of medical device instruments and accessories, from initial concept through commercial launch. This role requires deep expertise in medical device development, regulatory pathways, operations, sterilization, biocompatibility, and cross-functional project management. The Senior Project Manager serves as a key driver of product innovation, compliance, and operational excellence within the organization. The Senior Project 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

• Define program strategy, execution pathways, and development milestones for I&A product lines.
• Drive alignment across engineering, clinical, operations, and product management teams to ensure product and portfolio goals are met.
• Lead decision-making forums, business reviews, and roadmap integration discussions with senior leadership.

Product & Design Development

• Lead cross-functional teams through concept development, design iteration, prototyping, verification/validation, and design transfer to manufacturing.
• Maintain clear project plans, schedules, risks, and resource allocation.
• Partner with design, human factors, and engineering teams to ensure product requirements, usability, and performance criteria are met.

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.

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.

Skills, Experience, Education, & Training:

Required:

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• Minimum of 7 years’ experience in medical device product development, with demonstrated leadership in instrument and accessory projects from concept to launch.
• In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485), submission requirements, and quality system regulations.
• Experience collaborating with engineering, operations, regulatory, quality, and clinical teams throughout all development phases.
• Exceptional communication and stakeholder-management skills.
• Strong organizational skills, including planning, prioritization, and risk management.

Preferred:

• Experience in robotic surgery, laparoscopic instrumentation, or electro-mechanical medical devices.
• PMP certification or formal project management training.
• Familiarity with ALM/PLM systems, Agile methodologies, and project management tools.
• Expertise in operations, manufacturing processes, sterilization methods (e.g., EtO, autoclave, gamma), and biocompatibility assessment.

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.

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.