Jobs at Artivion, Inc.

Inspect, test, and assemble mechanical heart valve components in a cleanroom using microscopes and measurement tools. Perform visual and dimensional inspections, leak and proof testing, operate furnaces and sealing/press equipment, document results, and package product per FDA/ISO procedures.

Perform detailed hand polishing, shaping, blending and visual/dimensional inspection of small On-X heart valve components using microscopes and precision tools. Operate cleaning and laser etch equipment, document results, maintain traceability and cleanliness, follow FDA/ISO procedures, and complete production tasks per schedule with minimal supervision.

Lead quality engineering for new product development and transfer to manufacturing. Develop and approve validation, qualification, and test methods; troubleshoot inspection and laboratory equipment; perform audits, CAPA investigations, risk management (FMEA), and sampling plans; ensure regulatory and quality system compliance across manufacturing. Serve as technical resource for inspection, metrology, and product verification and collaborate with cross-functional teams to resolve quality issues and support continuous improvement.

Perform cleanroom sewing and assembly of heart valve components, inspect parts and finished goods with a microscope, maintain production and inspection records, monitor and clean the cleanroom, batch components, follow GMP/ISO/FDA practices, meet quality and production targets, and work scheduled hours including overtime and Saturdays.

Maintain and operate the Quality Management System for medical device manufacturing. Support CAPA, internal/external audits, change control, nonconformance monitoring, KPI reporting, and continuous improvement activities.

Perform cleanroom sewing and final assembly of heart valve components, inspect parts with a microscope, maintain production and inspection records, batch components, follow cleanroom GMP, and meet quality and production targets.

The Process Engineer II provides engineering support for manufacturing, initiates process improvements, ensures SOP adherence, and collaborates on new product launches.