Sr. New Product Development (NPD) Engineer - Future Forward

Intuitive • Sunnyvale, CA

8d

About The Position

We are seeking a high-precision, detail-oriented Senior NPD 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.

Requirements

• 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.
• 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.

Nice To Haves

• 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

• 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.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees