Artivion, Inc. Benefits Overview

Performs sewing and assembly of mechanical heart valve components in a cleanroom. Inspects materials, assemblies, and finished products using a microscope; maintains production records; batches components; supports cleanroom monitoring, cleaning, and testing; and follows GMP, FDA, ISO, safety, quality, and production standards. Requires detailed hand work, good eye-hand coordination, and availability for the stated weekday schedule, overtime, and Saturdays.

Monitors and interprets global medical device regulations, standards, legislation, and regulatory trends. Assesses business impacts, manages compliance risks, advises cross-functional teams, and drives implementation of regulatory changes. Maintains regulatory intelligence systems, supports submissions, audits, inspections, quality processes, and SOP updates. Leads complex projects, develops regulatory strategies, partners with agencies and industry organizations, and serves as a regulatory subject matter expert and mentor.

Performs cleanroom sewing and assembly of mechanical heart valve components, including inspecting materials and finished goods with a microscope, packaging, batching components, maintaining production records, and monitoring cleanroom conditions. Follows manufacturing instructions, Good Manufacturing Practices, safety procedures, and quality standards. The role requires consistent production performance, microscope use, detailed hand work, and availability for the scheduled shift, overtime, and Saturdays.