Senior Project Manager Advanced Energy Devices

Senior Project Manager Advanced Energy Devices

The Senior Project Manager Advanced Energy Devices on the Future Forward PMO team will be responsible for leading the end-to-end development of advanced energy medical devices, including ablation and resection capital equipment. The Senior Project Manager drives innovation and operational excellence within the advanced energy group, ensuring products meet rigorous design, clinical, regulatory requirements and organizational objectives. This position oversees complex product development workstreams specific to advanced energy devices, from initial concept through commercial launch, and ensures all products comply with FDA, EU MDR, ISO, and relevant quality system standards.

Roles & Responsibilities:

• Guide project team members in effective project scoping, scheduling, budget and resource allocation, and risk assessment for advanced energy device development.
• Manage the product lifecycle for advanced energy devices, overseeing concept generation, design, prototyping, verification and validation, regulatory submissions, manufacturing transfer, and commercial launch for both high and low voltage systems.
• Facilitate collaboration among R&D, Regulatory Affairs, Quality Assurance, Operations, Manufacturing, Clinical, Marketing, and external partners to integrate technical, clinical, and commercial requirements for advanced energy technologies.
• Guide teams in executing verification and validation for energy-based devices, including bench verification, pre-clinical and clinical testing, electrical safety testing, ensuring compliance with regulatory and quality standards.
• Support the preparation, submission, and management of regulatory documentation (e.g., IDE, 510(k), CE Mark, Technical Files) for advanced energy devices, supporting successful approvals and market entry.
• Support operational readiness for advanced energy products, including manufacturing scale-up, supply chain coordination, inventory management, and logistics for capital equipment launch.
• Implement rigorous risk management practices throughout the project lifecycle including establishing and maintaining project risk registers, decision matrices and escalation pathways.
• Maintain high-quality project documentation, reporting, and data integrity to support internal and external audits, inspections, and regulatory reviews associated with advanced energy technologies.
• Drive continuous improvement in advanced energy product development processes, leveraging industry best practices and lessons learned to enhance efficiency, quality, and compliance.
• Engage key stakeholders through regular reviews, status updates, and decision-making forums, ensuring transparent communication and organizational alignment for advanced energy projects.

Qualifications:

Skills, Experience, Education, & Training:

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or a related technical field; advanced degree preferred.
• Advanced organizational, planning, and prioritization skills; proficiency in project management tools and methodologies (MS Project, SmartSheet, Agile, Waterfall).
• Minimum 8 years' experience in advanced energy medical device product development, with proven leadership in ablation and resection capital equipment, instruments, and accessories from concept to launch.
• Regulatory Acumen: Strong understanding of medical device standards, advanced energy device regulatory requirements, and submission processes (FDA, EU MDR, ISO 13485).
• Demonstrated success managing cross-functional teams in regulated environments, delivering high-quality advanced energy products on schedule and within budget.

Nice to have:

• Excellent written and verbal communication skills, adept at presenting advanced energy technical and regulatory information to senior leadership, regulatory authorities, and external partners.
• Leadership: Ability to inspire, influence, and drive multidisciplinary teams toward common goals focused on advanced energy technology innovation and compliance.
• Problem Solving: Proactive in identifying issues, developing robust solutions, and managing project risks for advanced energy device development.
• Collaboration: Experience working with internal and external stakeholders across multiple disciplines in advanced energy technology projects.
• Attention to Detail: Commitment to accuracy, quality, and data integrity in all aspects of project management and documentation.

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 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.