Senior Project Manager – Advanced Energy Devices

Intuitive; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive is seeking a Senior Project Manager – Advanced Energy Devices on the Future Forward PMO team to lead end-to-end development of ablation and resection capital equipment. You will drive innovation, manage scoping, schedule, budget, and resource allocation, and ensure compliance with FDA, EU MDR, ISO, and quality standards.

You will coordinate cross-functional teams across R&D, Regulatory, QA, Operations, Manufacturing, Clinical, Marketing, and external partners to align technical,

Qualifications

• 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, including concept generation, design, prototyping, verification & validation, regulatory submissions, manufacturing transfer, and launch.
• Facilitate cross-functional collaboration across R&D, Regulatory, QA, Operations, Manufacturing, Clinical, Marketing, and partners to align technical, clinical, and commercial requirements.
• Guide teams in executing verification and validation for energy-based devices, including bench, pre-clinical and clinical testing, ensuring regulatory compliance.
• Support preparation, submission, and management of regulatory documentation (IDE, 510(k), CE Mark, Technical Files) for advanced energy devices.
• 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 throughout the project lifecycle, including risk registers, decision matrices and escalation pathways.
• Maintain project documentation, reporting, and data integrity to support audits, inspections, and regulatory reviews.
• Drive continuous improvement in energy product development, leveraging best practices to enhance efficiency, quality and compliance.
• Engage stakeholders through regular reviews and updates, ensuring transparent communication and alignment for advanced energy projects.

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.

Job description

Job Description

Primary Function of Position:

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.