Company Description
Company Description:
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.
Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.
The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.
If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.
Job Description
We are seeking a high-precision, detail-oriented Senior Project Engineer to perform the technical execution and requirements strategy for our new advanced energy platform. This position is focused on the management of the medical device product journey: from the first clinical requirement to the logistics of the product launch.
You will be the "glue" between the Technical Lead and the clinical site, ensuring that every design control is met and every piece of hardware needed for clinical studies is exactly where it needs to be, when it needs to be there.
1. Requirements Management & Design Controls
- Traceability Ownership: 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.
- Regulatory Compliance: Ensure all system-level documentation complies with ISO 13485 and FDA 21 CFR 820. You are the guardian of the Design History File (DHF).
- Clinical Translation: Act as the primary translator, converting "the voice of the customer" and usability feedback into rigorous, testable engineering specifications.
2. Launch Logistics & Clinical Study Support
- Detailed Logistics Planning: Manage the critical path for hardware delivery to clinical study sites, including supporting regulatory submission, labeling compliance, and shipping logistics.
- Inventory & Build Management: 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.
- Site Support Coordination: Ensure that clinical teams have the necessary technical documentation, IFUs (Instructions for Use), and troubleshooting guides to execute successful trials.
3. Project Management & Tech Lead Synergy
- Timeline Integration: Work in lockstep with the Technical Lead to ensure that technical milestones (Board bring-up, Firmware freezes) align with the overarching product launch schedule.
- Status Communication: Provide clear, data-driven status updates to cross-functional teams (Marketing, Regulatory, Quality) regarding requirement completion and project risks.
- Aggressive Schedule Execution: Identify "bottleneck" logistics early and implement workarounds to keep the project on track without compromising safety or quality.
Qualifications
Technical Essentials
- Education: BS in Engineering. An electrical background is a significant plus, as it allows you to better understand the nuances of our energy delivery system.
- Experience: 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.
- Regulatory Mastery: Deep understanding of Design Controls (21 CFR 820.30) and Risk Management (ISO 14971).
- Detail-Oriented Mindset: 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.
Soft Skills
- Exceptional Communication: The ability to explain technical project status to clinical staff and vice-versa.
- "Connecting the Dots": 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.
- People Skills: While you may not be managing direct reports, you must influence and lead cross-functional teams through collaboration and professional credibility.
Preferred Skills
- 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).
Additional Information
Working Conditions
- International Travel required (5-10%)
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
Base Compensation Range Region 1: $151,700 USD - $218,300 USD
Base Compensation Range Region 2: $128,900 USD - $185,600 USD
Shift: Day
Workplace Type: Onsite - This job is fully onsite.
