Senior Project Manager - Instruments & Accessories
Core
Leading the full product development lifecycle of medical device instruments and accessories from concept to commercial launch, ensuring compliance with FDA, EU MDR, and ISO standards.
Role type
Senior Project Manager (Medical Devices)
Builds
Medical device instruments and accessories for robotic surgery and minimally invasive care
Domain
Medical Devices / Robotic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device product development lifecycle management, Regulatory pathway expertise (FDA, EU MDR, ISO 13485), Cross-functional team leadership, Strategic program planning, Risk management, Manufacturing transfer coordination
Preferred skills
Robotic surgery instrumentation experience, PMP certification, ALM/PLM systems proficiency, Sterilization and biocompatibility knowledge
Technologies
ALM/PLM systems, Agile methodologies
Responsibilities
Define program strategy and execution pathways for I&A product lines, Lead cross-functional teams through design iteration and verification/validation, Drive manufacturing readiness and launch planning, Ensure project deliverables meet US and global medical device standards, Coordinate cross-functional preparation of regulatory documentation, Lead decision-making forums with senior leadership
Seniority
Senior, hands-on IC