Years Experience: 5 years Skills: Execute production schedules Train Tendyne Specialists Document training Adhere to and train to GMP and ISO compliance Assemble heart valves in accordance with approved manufacturing procedures Perform in-process quality checks on specialists, sub-assemblies and finished product Utilize small hand tools, calibrated instruments, measuring equipment, microscopes and test fixtures Participate in meetings as requested Work with specialists, engineers, and supervisor to resolve line issues and suggest improvements Maintain clean room integrity by using proper attire and adherence to clean room environment practices and procedures Maintain accurate documentation records related to quality, work in progress, test results, and special projects Adhere to and support general safety rules, manufacturing procedures, company policies and procedures, QSR and FDA regulations Proficient in basic assembly procedures Build and evaluate prototype components and devices Provide input for performance evaluations
What you will be doing: • Training Support for 30-45 DL operators • Medical assembly production training experience • Updating systems when workers are working through training • Not necessarily hands on training - but need understanding of certifications and line reviews; making sure workers are following process and compliance • Working with new operators through onboarding and continued training • Core training, gowning requirements, etc. completed prior to starting • Outgoing, people person, good communication skills • Needs manufacturing experience, preferred med device • Good with computers - LMS (learning manufacturing systems) • Reporting, maintaining training metrics and being able to report these to managements • Keeping up to date - making sure trainings are completed on time and not overdue • 2-3 years' experience training in Med Device, 4-5 years' experience training in manufacturing production
MS Office experience required; Windchill, LMS, SAP nice to have