Principal Manufacturing Engineer - Implantable Device Unit
Core
Drive manufacturing strategies, scale-up, and lifecycle management for Class III implantable drug delivery systems, ensuring compliance and scalability from development to commercialization.
Role type
Principal Manufacturing Engineer (Strategic IC with cross-functional influence)
Builds
Scalable, compliant manufacturing processes and supply chain operations for implantable medical devices
Domain
Medical Devices / Biotechnology / Implantable Drug Delivery Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing scale-up, process validation, FDA QSR/ISO 13485/ISO 14971 compliance, contract manufacturer management, cross-functional leadership, manufacturing technology roadmapping, multi-component assembly troubleshooting
Preferred skills
Experience with Class III implantable devices, drug delivery systems, external industry engagement, strategic partnership development
Technologies
None explicitly listed
Responsibilities
Lead end-to-end manufacturing strategy and lifecycle management; Define and implement manufacturing standards and control strategies; Serve as primary technical authority with contract manufacturers; Influence cross-functional decisions on development, quality, and supply chain; Drive manufacturing technology roadmaps and continuous improvement; Represent the organization in industry forums; Transfer new product designs into scalable manufacturing processes; Establish inspection strategies and validation plans; Evaluate suppliers and optimize supply chain processes; Select and optimize manufacturing processes and tooling
Seniority
Principal, strategic IC with cross-functional influence
