Sr. Project Engineer - Future Forward

Intuitive•Sunnyvale, CA

21h

About The Position

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for technologies like the da Vinci surgical system and Ion. The company's purpose is to make surgery smarter, safer, and more human, improving outcomes for millions of patients worldwide. The Future Forward organization is Intuitive’s advanced concepts group, focused on exploring emerging technologies, prototyping next-generation solutions, and building software experiences for the future of robotic-assisted surgery. This Senior Project Engineer position is within the Future Forward organization and is responsible for the technical execution and requirements strategy for a new advanced energy platform. The role involves managing the medical device product journey from clinical requirement to product launch, acting as the "glue" between the Technical Lead and the clinical site, ensuring design controls are met and hardware for clinical studies is delivered precisely when and where needed.

Requirements

BS in Engineering.
Typically requires a minimum of 8 years of related experience with a University degree; or 6 years’ experience and a Master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
Deep understanding of Design Controls (21 CFR 820.30) and Risk Management (ISO 14971).
Proven track record of managing complex logistics—you are the person who catches the small error in a label or a requirement before it becomes a major delay.
The ability to explain technical project status to clinical staff and vice-versa.
You see how a minor change in a clinical requirement ripples through the supply chain and the electrical architecture and inform the change to the technical lead.
You must influence and lead cross-functional teams through collaboration and professional credibility.

Nice To Haves

An electrical background is a significant plus.
Experience with Advanced Energy devices (RF, Microwave, PEF, Cryo, Ultrasound, etc.).
Experience managing the logistics of multi-center clinical trials.
Proficiency with Project Management tools (Jira, Smartsheet) and Requirements Management software (Jama, DOORS, Polarion, or Excel).

Responsibilities

Own the Requirements Management process (using tools like Jama, DOORS, Polarion, or Excel), ensuring 100% traceability between User Needs, System Requirements, and V&V testing.
Ensure all system-level documentation complies with ISO 13485 and FDA 21 CFR 820. You are the guardian of the Design History File (DHF).
Act as the primary translator, converting "the voice of the customer" and usability feedback into rigorous, testable engineering specifications.
Manage the critical path for hardware delivery to clinical study sites, including supporting regulatory submission, labeling compliance, and shipping logistics.
Coordinate with manufacturing and supply chain to ensure that clinical-grade units are built to the correct revision and are available to meet the aggressive study timeline.
Ensure that clinical teams have the necessary technical documentation, IFUs (Instructions for Use), and troubleshooting guides to execute successful trials.
Work in lockstep with the Technical Lead to ensure that technical milestones (Board bring-up, Firmware freezes) align with the overarching product launch schedule.
Provide clear, data-driven status updates to cross-functional teams (Marketing, Regulatory, Quality) regarding requirement completion and project risks.
Identify "bottleneck" logistics early and implement workarounds to keep the project on track without compromising safety or quality.