Senior Project Manager - Instruments & Accessories

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.

We're 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.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

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 work streams.

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.
• 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…