Intuitive · 4 hours ago
Manager, New Product Development (NPD) Engineering
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$167K/yr - $240K/yr
8+ years expIntuitive is a global leader in robotic-assisted surgery and minimally invasive care. They are seeking a detail-oriented NPD Engineering Manager to lead the technical execution and requirements strategy for a new advanced energy platform, ensuring compliance and effective logistics for product launch.
Health CareManufacturingMedical Device
Responsibilities
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
Launch Logistics & Clinical Study Support
Detailed Logistics Planning: Manage the critical path for hardware delivery to clinical study sites, including overseeing sterilization validation, 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
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
Qualification
Required
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: 8+ years in the medical device industry, specifically in New Product Development (NPD)
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
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
Typically requires at least 8 years as an individual contributor in Electrical Engineering, Biomedical Engineering, or a related field and 1-3 years as a people manager or prior management responsibilities through project management or team leadership efforts
Minimum University education required, plus requisite years of experience. An advanced degree in Electrical Engineering, Biomedical Engineering, or a related field is preferred
Preferred
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)
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
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