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.

Qualifications :

Skills Experience Education & Training:

Required:

• Bachelors 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.

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