Senior Project Manager – Advanced Energy Devices

Job description

Job 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…
• Facilitate collaboration among R&D, Regulatory Affairs, Quality Assurance, Operations, Manufacturing, Clinical, Marketing, and external partners to integrate technical, clinical, and commercial requirements for…
• 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…
• 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.

Job requirements

• 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.