Project Manager – Regulatory & Global Operations

***Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Project Manager on a contract basis to support our Customer's business needs. This role is on-site in Sunnyvale, CA.

The Project Manager within Portfolio Lifecycle Operations (PLO) is responsible for leading cross-functional, global project management activities across the full lifecycle of Intuitive’s multi-port product portfolio. Reporting to the Senior Manager of PLO, this role drives commercialization readiness, oversees product introduction and obsolescence workflows, and ensures alignment across commercial, operational, and technical functions.

Responsibilities:

• Manage project deliverables and launch execution through product design control processes to support regional product expansion
• Partner with global cross-functional teams, including regulatory, quality, logistics, trade compliance, PMO, and commercial teams, to ensure launch readiness
• Develop project timelines, critical paths, and risk mitigation plans
• Identify and escalate risks that may impact commercialization timelines
• Facilitate core team meetings to ensure alignment on risks, dependencies, and decisions
• Evaluate regional regulatory and compliance requirements and coordinate scalable process development
• Lead project management efforts for first-time market entry and product adoption initiatives
• Oversee Approved Product List (APL) operations, including design control, import readiness, and post-launch support
• Drive development of tools, processes, and systems to improve operational efficiency and lifecycle management
• Analyze key performance indicators and operational data to generate insights
• Prepare and present reports and recommendations to executive leadership

Skills and Qualifications:

• Bachelor’s degree or equivalent practical experience
• 6+ years of relevant experience in project management, operations, or related functions
• Minimum 2 years of experience in medical device project management or related areas such as regulatory, logistics, or operations
• Minimum 4 years of experience in business process development, operational excellence, or change management
• Strong project management skills with experience leading complex, cross-functional programs
• Ability to manage multiple projects in a fast-paced, global environment
• Strong organizational, documentation, and communication skills
• Experience with risk management, planning, and execution of large-scale initiatives
• Ability to work across global teams and time zones
• Strong analytical skills with experience using data to inform decisions

Preferred Qualifications

• Experience with international medical device markets and regulatory requirements
• Knowledge of product design, control, and downstream logistics operations
• Experience with complex regulated hardware or software systems
• Familiarity with PLM systems and product configuration management
• Experience with global commercialization requirements across regions such as Japan, China, the EU, and the UK
• Experience collaborating with product management on lifecycle execution
• Master’s degree in Engineering or Business Administration
• PMP certification

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.