Senior Project Manager – Advanced Energy Devices
Core
Leading end-to-end development of advanced energy medical devices (ablation and resection capital equipment) from concept through commercial launch, ensuring compliance with FDA, EU MDR, and ISO standards.
Role type
Senior Project Manager (Medical Device Development)
Builds
Advanced energy medical devices (high and low voltage systems) for clinical use
Domain
Medical Technology / Advanced Energy Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project scoping, scheduling, budget and resource allocation, risk assessment, product lifecycle management, cross-functional team leadership, regulatory submission management, manufacturing scale-up coordination, risk register management, data integrity maintenance
Preferred skills
Advanced degree in engineering, proficiency in MS Project/SmartSheet/Agile/Waterfall, experience presenting technical/regulatory info to senior leadership, inspiring multidisciplinary teams, proactive problem solving, stakeholder collaboration, attention to detail
Technologies
MS Project, SmartSheet, Agile, Waterfall
Responsibilities
Guide project team members in effective project scoping, scheduling, budget and resource allocation, and risk assessment; Manage the product lifecycle for advanced energy devices; Facilitate collaboration among R&D, Regulatory Affairs, Quality Assurance, Operations, Manufacturing, Clinical, Marketing, and external partners; Guide teams in executing verification and validation for energy-based devices; Support the preparation, submission, and management of regulatory documentation; Support operational readiness for advanced energy products; Implement rigorous risk management practices throughout the project lifecycle; Maintain high-quality project documentation, reporting, and data integrity; Drive continuous improvement in advanced energy product development processes; Engage key stakeholders through regular reviews, status updates, and decision-making forums
Seniority
Senior, hands-on IC