MedTech Program Manager - Systems & Launch

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 171,000 - 289,000; Full time

Job summary

Intuitive Surgical, Inc. is seeking a seasoned Program Manager to lead the full lifecycle of capital medical device systems from concept through launch.

You will coordinate engineering, operations, regulatory, and clinical teams to ensure design controls, risk management, and timely escalation are in place. The role requires deep regulatory knowledge (FDA, EU MDR, ISO 13485), strong program planning, and exceptional communication skills to align stakeholders and drive successful product

Qualifications

• Bachelor's degree in Mechanical, Electrical or Biomedical Engineering or related field.
• At least 10 years of experience leading complex medical device development programs, including capital equipment or system-level products, from concept to launch.
• In-depth knowledge of medical device regulatory pathways (FDA, EU MDR, ISO 13485) and quality system regulations.
• Proven ability to lead cross-functional teams and manage multiple large projects.

Responsibilities

• Shape program strategy, roadmap priorities, and execution plans with leaders across functions.
• Lead design development, prototyping, verification/validation, and design transfer to manufacturing.
• Drive manufacturing readiness, supply chain coordination, and launch planning.
• Ensure regulatory documentation and testing are prepared; maintain governance and accountability.

Skills

Strategic Leadership

Cross-functional leadership

Regulatory knowledge

Program management

Design controls

Communication

Education

Bachelor's in Mechanical, Electrical or Biomedical Eng

Advanced degree preferred

Tools

ALM/PLM systems

Project management tools

Agile methodologies

Job description

Intuitive Surgical, Inc. is seeking a seasoned Program Manager to lead the full lifecycle of capital medical device systems from concept through launch.

You will coordinate engineering, operations, regulatory, and clinical teams to ensure design controls, risk management, and timely escalation are in place. The role requires deep regulatory knowledge (FDA, EU MDR, ISO 13485), strong program planning, and exceptional communication skills to align stakeholders and drive successful product