MedTech Systems Program Lead

Intuitive; Sunnyvale (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Intuitive seeks a Program Manager to lead the full product development lifecycle of medical device capital systems, from concept through launch. You will drive strategy, cross-functional execution, and regulatory submissions to ensure compliant, manufacturable solutions.

Responsibilities include leading design controls, R&D-to-operations transition, and ongoing lifecycle management while partnering with finance on budgets and risks.

Qualifications

• Experience leading medical device development programs.
• Strong understanding of design controls and risk management.
• Familiarity with FDA, EU MDR, ISO standards and quality systems.

Responsibilities

• Strategic leadership to shape program strategy, roadmap priorities, and execution plans.
• Align engineering, clinical, regulatory, and product teams to meet goals.
• Facilitate program reviews and structured decisions to resolve issues.
• Lead cross-functional negotiations and stakeholder alignment.
• Drive manufacturing readiness and launch planning across functions.
• Coordinate regulatory documentation and testing throughout lifecycle.

Skills

Program management

Cross-functional leadership

Regulatory knowledge

Quality systems

Risk management

Design controls

V&V

Job description

Intuitive seeks a Program Manager to lead the full product development lifecycle of medical device capital systems, from concept through launch. You will drive strategy, cross-functional execution, and regulatory submissions to ensure compliant, manufacturable solutions.

Responsibilities include leading design controls, R&D-to-operations transition, and ongoing lifecycle management while partnering with finance on budgets and risks.