Staff Plastics Engineer
Core
Provide technical leadership in the development, commercialization, and lifecycle management of injection molded plastic components, assemblies, materials, tooling, automation systems, and manufacturing processes for diagnostic instruments and fluidic systems.
Role type
Staff Plastics Engineer (Senior IC)
Builds
Diagnostic instruments, consumables, cartridges, fluidic systems, and automation platforms
Domain
Life sciences / Clinical diagnostics / Injection molding
Required skills
Injection molding, mold design, tooling development, process validation, material selection, Design Controls, regulatory compliance (FDA/ISO 13485), cross-functional project leadership, supplier management, root-cause analysis
Preferred skills
Medical device experience, FMEA, Risk Management, Design History File (DHF), Mold flow analysis, Design of Experiments (DOE), automation systems, global supplier qualification
Technologies
Injection molding machines, mold flow analysis software, automation systems, Design Controls software
Responsibilities
Lead design and development of injection molded plastic components from concept to commercialization; Drive engineering change ownership and change control execution; Provide technical leadership for material selection, mold design reviews, and process validation; Establish and maintain technical documentation for regulatory submissions; Partner with global suppliers to improve manufacturability and quality; Ensure compliance with quality system requirements and international regulatory standards
Seniority
Staff, technical leadership & cross-functional project lead