Our client is a bioelectric medicine company developing CellFX nsPFA (nanosecond Pulsed Field Ablation) technology, which delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent non-cellular tissue.
The company is advancing this technology for the surgical treatment of atrial fibrillation and select percutaneous applications with the potential to meaningfully improve patient outcomes.
Seeking a new Sr. Project Manager of Electrical Engineering will lead and manage multiple electrical engineering projects within R&D, driving project planning, resourcing, and scheduling to successful conclusion.
This role organizes and leads multifunctional teams, accelerates interdepartmental cooperation, and ensures program completion on schedule, within budget, and to a high quality standard.
RESPONSIBILITIES
- Lead product development cross‑functional project teams from concept to launch, fostering effective teamwork among internal and external stakeholders
- Manage and mitigate overall project risk through planning, prioritization, and clear communication of critical issues
- Provide regular status updates to stakeholders on project progress and outcomes
- Serve as the primary point of contact for assigned projects, resolving and escalating issues as needed
- Develop deep understanding of each product's clinical purpose, key features, and technical challenges
- Maintain working knowledge of each project's regulatory and quality strategy and its priority within the company portfolio
- Monitor project scope, schedule, and cost to keep programs on track against internal and vendor commitments
- Partner with other project managers to align cross‑functional dependencies and integrated schedules across hardware, firmware, and software
- Drive change control processes to meet financial performance targets
- Ensure quality control and risk management deliverables meet regulatory, clinical, and manufacturing requirements
- Monitor progress against design control requirements and revise project plans per SOPs as needed
- Support continuous improvement of engineering capabilities within the scope of design control
QUALIFICATIONS
- BS in Electrical Engineering or related engineering discipline required
- 8+ years of experience in electrical‑related product development
- 5+ years of experience in medical device or combination device development, engineering management, project management, or technical leadership
- Experience with Design Controls and Medical Device Directive/Regulation
- Working knowledge of hardware and software development methodologies
- Understanding of FDA Design Controls guidance, MDD/MDR requirements, and IEC 60601, IEC 62304, and ISO 14971 standards
- Proficiency in MS Project, SmartSheet, or similar planning tools
- Strong leadership, cross‑functional collaboration, and communication skills