Sr. Manager, R&D

About this role

Responsibilities

• Lead the design, prototyping, and evaluation of innovative transplant devices, integrating advanced technologies to enhance organ preservation methods.
• Assess potential intellectual property opportunities related to organ transplantation and preservation.
• Oversee projects from concept through feasibility, verification, validation, and design transfer to manufacturing, ensuring compliance with ISO 13485 and FDA regulations.
• Partner with marketing, regulatory affairs, quality assurance, and manufacturing teams to ensure regulatory compliance and commercial feasibility.
• Review design outputs (e.g., schematics, CAD models, PCB layouts) and manage design controls to minimize risks (ISO 14971).