Sr Project Manager

Senior Project Manager leads full product development lifecycle for medical device endoscopes and vision systems, from concept through commercial launch. The role requires deep expertise in medical device regulations, cross-functional team leadership, and operational excellence to ensure compliance with FDA, EU MDR, and ISO standards.

Responsibilities

• Execute development plans aligned with product roadmap and lead cross-functional teams through concept to commercial launch
• Develop project execution plans, milestones, and schedules; facilitate program reviews with functional and senior leaders
• Lead design development, prototyping, verification/validation, and manufacturing transfer for optical, mechanical, and imaging solutions
• Drive manufacturing readiness, supply chain coordination, and transition from R&D to operations with documentation rigor
• Ensure regulatory compliance and coordinate preparation of FDA, EU MDR, and ISO documentation across workstreams

Requirements

• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering or related technical field
• Minimum 7 years medical device product development experience with endoscope or vision project leadership
• In-depth knowledge of FDA, EU MDR, ISO 13485 regulatory pathways and quality system requirements
• Demonstrated ability to lead cross-functional teams through all development phases
• Exceptional communication and stakeholder management skills
• Strong project planning, prioritization, and risk management capabilities
• Ability to manage multiple concurrent projects while handling ambiguity