Intuitive
Healthcare
Sr.ProjectEngineer
Neural analysis suggests this role is
optimal for mid candidates.
“Sr. Project Engineer at Intuitive. Skills: Requirements Management, Design Controls, Launch Logistics, Clinical Study Support, Project Management. Perform the technical execution and requirements strategy for our new advanced energy platform. Management of the medical device product journey: from the first clinical requirement to the logistics of the product launch”
What You'll Achieve.
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; Ensure that every design control is met; Ensure every piece of hardware needed for clinical studies is exactly where it needs to be, when it needs to be there; Ensure that clinical teams have the necessary technical documentation, IFUs (Instructions for Use), and troubleshooting guides to execute successful trials; Ensure that technical milestones align with the overarching product launch schedule; Keep the project on track without compromising safety or quality
Industry & Context.
Identify 'bottleneck' logistics early and implement workarounds
International Travel required (5-10%), Proof of vaccination against certain diseases including COVID-19 may be required, May be subject to U. S. export controls, 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
What They're Looking For.
Must Have
BS in Engineering, 8 years of related experience with a University or 6 years’ experience and a Master’s or a PhD with 3 years’ or equivalent experience, Deep understanding of Design Controls (21 CFR 820. 30), Deep understanding of Risk Management (ISO 14971), Proven track record of managing complex logistics
Nice to Have
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), Proficiency with Requirements Management software (Jama, DOORS, Polarion, or Excel)
What You'll Do.
Perform the technical execution and requirements strategy for our new advanced energy platform
Management of the medical device product journey: from the first clinical requirement to the logistics of the product launch
Own the Requirements Management process
Ensure all system-level documentation complies with ISO 13485 and FDA 21 CFR 820
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
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 align with the overarching product launch schedule
data-driven status updates to cross-functional teams regarding requirement completion and project risks
Identify 'bottleneck' logistics early and implement workarounds to keep the project on track without compromising safety or quality
How You'll Work.
Team & Collaboration
Act as the 'glue' between the Technical Lead and the clinical site; Work in lockstep with the Technical Lead; Provide clear, data-driven status updates to cross-functional teams (Marketing, Regulatory, Quality)
Communication Scope
Exceptional Communication; The ability to explain technical project status to clinical staff and vice-versa
Process & Methodology
Project Management, Timeline Integration, Aggressive Schedule Execution
Full Job 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. 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 Requir
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