Job Description
Primary Function of Position:
The Senior Project Manager is responsible for leading and executing the full product development lifecycle of medical device endoscopes and end to end vision pipeline, 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 leads cross-functional execution across all phases of product development, from concept through commercial launch, 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.
- Execute development plans aligned with product roadmap objectives.
- Develop project execution plans, development milestones, and cross-functional plans for Endoscope development programs.
- Facilitate program reviews and decision-making discussions with functional and senior leaders to resolve issues, align priorities, and maintain program momentum.
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 engineering teams to drive development of optical, mechanical, illumination, imaging, and sterilization solutions that meet product performance requirements.
- Coordinate verification and validation activities, ensuring successful execution of testing, defect resolution, and readiness for regulatory submissions.
- Lead comprehensive risk management across multiple workstreams by ensuring risks are identified, analyzed, prioritized, communicated, and used to inform trade-off decisions.
- Translate technical, regulatory, operational, and business content into accessible written and oral communications for varied audiences, including reports, project updates, decision summaries, and leadership deliverables.
Operational Execution
- Drive manufacturing readiness, including process development, supply chain coordination, build readiness, launch planning, budget inputs, financial assumptions, and cross-functional execution across multiple workstreams.
- 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 and functional leaders to validate financial assumptions, provide budget inputs across workstreams, monitor project financials, and manage trade-offs to remain within approved commitments.
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:
- Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
- At least a minimum of 7 years’ experience in medical device product development, with demonstrated leadership in Endoscope or Vision 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.
- Ability to handle ambiguity effectively and oversee multiple medium size projects at once
- Strong organizational skills, including planning, prioritization, and risk management.
Preferred:
- Experience in robotic surgery, laparoscopic endoscopes, 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.
- Start-up experience desired
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 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 HRHelpNow@intusurg.com.
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.
Company Description
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, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.
Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.
The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.
If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.
