Sr Project Manager
Core
Lead the full product development lifecycle of medical device endoscopes and vision pipelines from concept to commercial launch, ensuring compliance with FDA, EU MDR, and ISO standards.
Role type
Senior Project Manager (Medical Device Development)
Builds
Endoscope products and end-to-end vision pipeline systems
Domain
Medical Devices / Surgical Robotics
Deliverable
production ML models | product features
Required skills
Medical device regulatory pathways (FDA, EU MDR, ISO 13485), cross-functional project management, risk management, manufacturing transfer, design controls, stakeholder management
Preferred skills
Robotic surgery experience, laparoscopic endoscopes, PMP certification, ALM/PLM systems, Agile methodologies, sterilization methods, biocompatibility assessment
Technologies
FDA, EU MDR, ISO 13485, ALM/PLM systems
Responsibilities
Execute development plans aligned with product roadmap; lead cross-functional teams through concept, design, prototyping, and validation; drive manufacturing readiness and supply chain coordination; coordinate regulatory documentation and testing; manage project financials and trade-offs
Seniority
Senior, hands-on IC