Senior Project Manager - Instruments & Accessories

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.

Experience in robotic surgery, laparoscopic instrumentation, or electro-mechanical medical devices.

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.

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.

Strategic Leadership

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at

Intuitive

. As a global leader in

robotic-assisted surgery

and

minimally invasive care