Manager, New Product Development (NPD) Engineering

Primary Function of Position 
We are seeking a high-precision detail-oriented NPD Engineering Manager to lead the
technical execution and requirements strategy for our new advanced energy platform. Unlike
a traditional people-manager role this position is focused on the management of the 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.

Essential Job Duties (Specific responsibilities and tasks an
individual would be expected to perform in the role. Additional job duties may be determined by
functional people manager)

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 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.

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 :

Required Skills and Experience 
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: 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 logisticsyou 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.

People Skills

While you may not be managing direct reports you must influence and lead cross-functional teams through collaboration and professional credibility.

Required Education and Training 

• 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 Skills and Experience 

• 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 :

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.

Mandatory Notices

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 employeeswho 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 governments 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 employeesstart 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.

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.

Remote Work :

No

Employment Type :

Full-time