Senior Medical Device Systems Program Manager

SmartRecruiters, Inc.; Sunnyvale (CA); On-site; USD 171,000 - 201,000; Full time

Job summary

Intuitive Surgical in Sunnyvale, CA seeks a Senior Program Manager to lead the full lifecycle of medical device capital systems from concept to launch. You will drive cross-functional teams, ensure regulatory compliance (FDA, EU MDR, ISO 13485), and coordinate manufacturing transfer with a focus on quality systems and risk management.

The role requires deep program planning, governance, and stakeholder management across engineering, clinical, regulatory, and operations to deliver safe, effective

Qualifications

• Bachelor’s degree in Mechanical, Electrical or Biomedical Engineering or a related technical field; advanced degree preferred.
• At least a minimum of 10 years' experience leading complex medical device development programs.
• Experience with regulatory pathways (FDA, EU MDR, ISO 13485) and quality system regulations.

Responsibilities

• Lead and execute full product development lifecycle for medical device capital systems.
• Coordinate cross-functional teams and regulatory submissions.
• Drive manufacturing readiness and program budgeting.

Skills

Leadership

Cross-functional

Communication

Program management

Regulatory knowledge

Education

Bachelor's degree in Mechanical, Electrical or Biomedical Engineering

Advanced degree preferred

Tools

PMP certification

ALM/PLM systems

Agile methodologies

Job description

Intuitive Surgical in Sunnyvale, CA seeks a Senior Program Manager to lead the full lifecycle of medical device capital systems from concept to launch. You will drive cross-functional teams, ensure regulatory compliance (FDA, EU MDR, ISO 13485), and coordinate manufacturing transfer with a focus on quality systems and risk management.

The role requires deep program planning, governance, and stakeholder management across engineering, clinical, regulatory, and operations to deliver safe, effective