R&D Technician I – Electrophysiology (central shift)

JOB PURPOSE

This position will support builds for new product development and transfer projects. Assembles and/or produces high-quality medical devices with experienced proficiency in machine and assembly operation and will be required perform minor setups

MAJOR RESPONSIBILITIES

• Support R&D builds using multiple machines or assembly processes. May include processes such as laser, reflow, adhesive bonding, etc.
• Overseeing the ongoing operations of the R&D Laboratory.
• Provide assistance in new process development and transfer activities, as well as in the coordination of lift & shift processes.
• Strong ability to train other Operators and Technicians; able to “train the trainer”.
• Completes all administrative functions relating to completion of orders, CAPEX, PO’s.
• Works with area Team Lead and/or engineers and / or Technicians / and / or Area Expert to develop and implement practical ideas. Solicits ideas for improved quality and productivity from production staff on an ongoing basis.
• Maintains a clean and organized work area to facilitate pilot manufacturing functions.

KNOWLEDGE, SKILLS AND ABILITIES

• High school diploma.
• Technical Degree in Engineering, Manufacturing, or related field.
• Active engineering student with no more than 25% of their degree completed.
• 0-3 years of hands-on experience in process development, manufacturing, or a related technical field.
• Written and Spoken English - intermediate/advanced (is a must).
• Experience in a regulated industry (GMP, ISO, FDA) is a plus.
• Knowledge of good documentation practices.
• Six sigma yellow/green belt (desirable).
• Experience in process development, materials handling, or technical manufacturing is desirable.
• Low/medium level of knowledge in process validation.
• Electromechanical aptitude and hands-on troubleshooting skills for manufacturing equipment.
• Low/medium knowledge of building medical catheters and equipment set up.
• Understands drawing/prints and product specifications is nice to have.
• Knowledge in using CAQ and SAP (preferred).