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.

- 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.

- 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.

- 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.

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.

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.

• 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. 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.

• 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.