Senior Project Manager – Advanced Energy Devices

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.