Director, Engineering
Core
Lead R&D product lifecycle management for implantable heart failure management devices, ensuring regulatory compliance and driving device improvements.
Role type
Senior IC engineering director (medical devices)
Builds
Implantable Heart Failure Management (IHFM) devices and related engineering tools
Domain
Medical device engineering / Structural heart disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering leadership, product lifecycle management, regulatory compliance (FDA/ISO), root cause analysis, team hiring and coaching, strategic planning, mechanical/electrical/data engineering knowledge
Preferred skills
Cross-functional team management, hands-on design/development participation, project management, financial acumen, global enterprise systems implementation
Technologies
ISO 13485, IEC 62304, 21 CFR Part 820, FDA submission tools
Responsibilities
Manage engineering aspects of product life cycle including design changes and component obsolescence; Develop and implement strategic plans for sustaining engineering activities; Hire, train, coach and review the work of a team of engineers; Monitor and evaluate product performance and continuously improve components; Provide strategic direction governing team and project priorities; Ensure proper design documentation and adherence to QMS; Lead team in root cause investigations and corrective actions; Collect, interpret, analyze, and present field performance data
Seniority
Senior, hands-on IC with management authority