Advanced Manufacturing Engineer
Core
Lead end-to-end industrialization for new medical products and design changes, ensuring compliance with FDA QSR/cGMP and ISO 13485 standards.
Role type
Senior IC manufacturing engineer (medical devices)
Builds
Regulated medical device products
Domain
Medical devices / Healthcare
Required skills
Industrialization, Design for Excellence (DFX), Design for Six Sigma (DFSS), Design of Experiments (DOE), Statistical Process Control (SPC), Equipment selection, Tooling development, IQ/OQ/PQ validations, Site-to-site transfers, Cost of Goods (COGS) optimization, Yield improvement, Stakeholder management, Supplier management
Preferred skills
Data-driven engineering methods, Automation strategies, Labor capacity planning
Technologies
FDA QSR, cGMP, ISO 13485, SPC, DOE, DFSS
Responsibilities
Initiate and lead end-to-end industrialization for new products and design changes, Integrate Design for Excellence (DFX) principles to optimize manufacturability and reliability, Drive key business metrics including COGS and yield, Apply data-driven engineering methods to resolve complex manufacturing issues, Partner across teams and suppliers to deliver regulated product launches
Seniority
Mid-level, hands-on IC