The purpose of this position is to conduct process research, process development and process upscaling for new medical device products. This role investigates and evaluates existing technology and designs new methodology, materials, machines and/or processes as needed for medical device development. This position also collaborates in development of automated instrumentation, machine vision, and robotic systems for use in research, development, and manufacturing of Intraocular Lenses (IOLs), IOL delivery systems, and surgical equipment.
Leads development work in hands-on environment to assemble and test machines in laboratory and clean environment conditions.
Utilizes agile development fundamentals to deliver innovative solutions in fast paced environment.
Identification, development, and qualification of technology solutions for R&D and Manufacturing.
Implements innovative approaches for delivering technology solutions faster and with higher quality.
Development of documentation and procedures for verification and validation of new and existing equipment in GxP environments.
Development of documentation and procedures for measurement system analysis (MSA), verification and validation of new and existing equipment.
Oversees build of machinery with troubleshooting, maintenance, and optimization of electrical sub-systems in laboratory and manufacturing environments.
Acts as subject matter expert to identify, design, build, and qualify automated instruments and automation equipment based on project requirements.
Coordinates and oversees sourcing and development of electro-optical instruments and sub-systems from partner vendors.
Evaluates and documents system compliance for CE registration of equipment.
Identification, development, and demonstration (proof-of-concept) of technology solutions.
May lead design reviews and review action items.
Ensures regulatory, statutory and/or legislative compliance for all project work.