Jobs at Artivion, Inc.

Supports daily logistics, shipping, receiving, inventory, and customer service tasks for medical device and human tissue products. Reviews orders, books shipments, receives products into SAP, verifies purchase orders, manages labeling and expiration data, transfers tissue to freezers, maintains supplies, and supports department on-call duties while following quality procedures.

Leads clinical studies from design and start-up through completion, managing protocols, regulatory submissions, sites, vendors, budgets, timelines, documentation, training, audit readiness, and study risks. Coordinates cross-functional teams, supports data review and query resolution, collaborates with statisticians and quality stakeholders, and serves as a primary contact for clinical partners. Requires domestic and international travel up to 30%.

Manage and oversee electronic Trial Master Files throughout clinical trial lifecycles, ensuring accurate, complete, timely, compliant, and inspection-ready documentation. Perform quality control, reconciliation, metrics monitoring, issue escalation, audit and inspection support, and collaboration with clinical teams, CROs, sites, Quality Assurance, and Regulatory Affairs. Train users, support SOP development, and assist with eTMF system enhancements and user acceptance testing.

Perform and document calibration activities for equipment and processes used in medical device manufacturing. Analyze calibration data statistically, support quality system and ISO compliance, review specifications, and help ensure products are reliable, safe, and effective. The role requires collaboration on quality procedures, process development, calibration programs, and regulatory compliance in an FDA-regulated environment.

Performs detailed hand polishing, shaping, blending, cleaning, laser etching, and dimensional inspection of intricate medical device components. Uses microscopes, reticles, profilometers, calipers, and polishing tools while maintaining component dimensions and quality standards. Documents traceability, follows FDA and ISO manufacturing practices, completes production tasks with minimal supervision, maintains equipment and work areas, and identifies process improvements.

Performs tissue dissection, aseptic allograft processing, inspection, documentation, equipment monitoring, instrument sterilization, laboratory cleaning, and material stocking. Ensures all activities comply with quality specifications and company SOPs. Receives and labels tissue, prepares solutions, maintains accurate records, and assists with training newer technicians. Requires a high school diploma, attention to detail, independence, and availability for the Friday through Sunday overnight schedule.

Performs tissue dissection, allograft processing, aseptic transfers, tissue receipt and inspection, laboratory instrument sterilization, solution preparation, equipment monitoring, documentation, and lab cleaning. Ensures work complies with quality specifications and company SOPs, maintains supplies and records, and assists with training newer technicians. The required schedule is Friday through Sunday, 4:00 PM to 2:30 AM.

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.

Performs cleanroom sewing and assembly of mechanical heart valve components, inspects materials and finished products using a microscope, maintains production records, batches components, and supports cleanroom monitoring and testing. The role requires adherence to detailed manufacturing instructions, FDA and ISO practices, Good Manufacturing Practices, quality standards, and production expectations. Technicians must work the assigned weekday schedule, accept overtime and Saturday work, and perform extended sitting or standing and lifting up to 25 pounds.

Supports technical documentation updates by identifying placeholders and missing information, researching software manuals with ChatGPT and approved resources, and incorporating verified information into documents. Responsibilities include checking AI-assisted results against source materials, preserving accuracy and formatting, proofreading, tracking completed work, escalating questions, and following document-control, confidentiality, and approved AI-use requirements.

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.

Operate and maintain the company Quality Management System, ensuring compliance with applicable regulations and standards. Coordinate CAPAs, nonconformances, audits, corrective actions, change control, management reviews, quality plans, and gap analyses. Administer eQMS software, report quality KPIs, support internal and external audits, provide training, and drive continuous improvement and timely closure of audit findings.

Drive sales growth for assigned endovascular products across the Southeast Region. Develop relationships with cardiac and vascular surgeons, provide clinical support during procedures, train operating-room personnel, and promote product adoption. Manage territory goals, pricing agreements, expenses, reporting, compliance, and administrative responsibilities while collaborating with regional managers, cardiovascular specialists, marketing, national accounts, and leadership. Frequent travel and overnight stays are required.

Performs histology services in an in-house pathology laboratory, including tissue processing, paraffin embedding, microtome sectioning, routine and special staining, gross examinations, specimen shipments, inventory management, and report support. Maintains tissue-processing equipment and supports pathologists and the Medical Director during a fixed Monday–Friday, 7:00 AM–4:00 PM schedule.

Drive sales and adoption of Artivion’s Nexus endovascular products across the West Region. Generate business with cardiac and vascular surgeons, provide clinical procedure support, train OR personnel, conduct in-services, manage customer relationships, attend medical meetings, support pricing agreements, maintain compliance, manage expenses, and achieve revenue and unit goals through effective territory planning and reporting.

Drive sales and adoption of Artivion’s Nexus endovascular products across the Midwest. Responsibilities include calling on cardiac and vascular surgeons, providing clinical procedure support, training operating-room personnel, conducting in-services, attending medical meetings and tradeshows, managing territory goals and expenses, supporting pricing agreements, maintaining compliance, and communicating market needs and performance to leadership. Frequent travel and overnight stays are required.

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.