Senior Medical Device Program Manager - Endoscope & Regulatory

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 151,000 - 217,000; Full time

Job summary

Intuitive Surgical, Inc. seeks a Senior Project Manager to lead the full lifecycle of medical device endoscope development from concept through commercial launch.

You will steward regulatory, sterilization, biocompatibility, and cross-functional program execution to ensure compliant, on-time delivery. The role requires 7+ years in medical device product development, strong communication, and the ability to manage multiple workstreams with rigor, while aligning with FDA/EU MDR/ISO standards and

Qualifications

• Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• At least 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.

Responsibilities

• Execute development plans aligned with product roadmap objectives.
• Develop project execution plans, development milestones, and cross-functional plans for Endoscope development programs.
• 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.

Skills

Project management

Cross-functional leadership

Communication

Leadership

Ambiguity tolerance

Risk management

Regulatory knowledge

Education

Bachelor's degree in Mechanical, Electrical or Biomedical Engineering

Advanced degree preferred

Tools

ALM/PLM systems

Agile methodologies

PMP certification

Job description

Intuitive Surgical, Inc. seeks a Senior Project Manager to lead the full lifecycle of medical device endoscope development from concept through commercial launch.

You will steward regulatory, sterilization, biocompatibility, and cross-functional program execution to ensure compliant, on-time delivery. The role requires 7+ years in medical device product development, strong communication, and the ability to manage multiple workstreams with rigor, while aligning with FDA/EU MDR/ISO standards and