Jobs at Artivion, Inc.

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

The role involves leading commercialization and marketing strategies for Artivion's endovascular portfolio, focusing on revenue growth and successful product launches while collaborating with cross-functional teams and key opinion leaders.

Perform tissue dissections and aseptic processing of allografts, inspect and document incoming tissue, maintain sterile/non-sterile lab operations, clean and sterilize instruments, monitor equipment, maintain supplies and accurate documentation, follow SOPs, and assist in training.

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.

Inspect, test, and assemble On-X mechanical heart valve components in a cleanroom. Perform visual and dimensional inspections using microscope and calipers, run leak/proof/peel tests, operate vacuum furnace, heat sealing, ultrasonic and press equipment, clean and package product, and document results per written FDA/ISO procedures.

Support daily shipping and receiving operations for medical devices, including order quality review, inventory management, SAP data entry, carrier coordination, RMA handling, cycle counts, and FDA compliance support. Perform general warehouse tasks, customer communication, and assist team functions with minimal supervision.

Lead end-to-end data management for medical device clinical trials: database build, EDC testing/UAT, DMP/CRF development, edit checks, data cleaning, reconciliation, medical coding (MedDRA/WHO-DD), reporting, audit readiness, regulatory compliance, cross-functional collaboration, and mentoring junior staff.

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 global strategic sourcing to mitigate supply risk, drive cost reductions, run competitive sourcing events, negotiate and execute supply agreements, manage supplier non-conformance resolution and supplier audits, and coordinate cross-functional stakeholders.

Coordinate creation, review, approval, release, and implementation of medical device product labels. Ensure regulatory and internal compliance, manage translations and proofs, support production with correct labels, perform quality checks, resolve discrepancies, document processes, and collaborate with Operations, Quality, Regulatory, Engineering, and Supply Chain to implement label changes and continuous improvements.

The Monitoring Oversight Lead will manage clinical monitoring activities, supervise CRAs, ensure compliance with regulations, and support clinical trial processes.

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 pathologist supports cardiac tissue donation by providing pathology examinations and critical reports for medical examiners, ensuring donor eligibility and compliance with regulations.

Perform tissue dissections and aseptic processing of allografts while maintaining compliance with quality specifications and safety protocols.

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