Jobs at Artivion, Inc.

Entry-level logistics coordinator supporting shipping and receiving operations for medical devices and human tissue products. Responsibilities include order quality review, booking shipments, inventory receiving, SAP data entry, product labeling, freezer transfers, vendor coordination, customer support, supply management, and on-call assistance. The role requires strong organization, communication, computer skills, adherence to quality procedures, and the ability to lift 70 pounds repeatedly.

Supports quality engineering for medical device new product development, manufacturing transfers, validations, nonconformance investigations, CAPA, risk management, design controls, sampling plans, and test method approvals. Partners with R&D and manufacturing teams to ensure products and processes comply with FDA regulations, Good Manufacturing Practices, Quality System Regulations, and ISO standards. Analyzes quality data and prepares validation and engineering study reports.

Inspects, tests, cleans, packages, and assembles mechanical heart valves and OEM components in a clean room environment. Performs visual and dimensional inspections using microscopes and measurement equipment, conducts leak and proof testing, operates specialized processing equipment, and documents results according to manufacturing procedures and quality requirements.

Dissects, processes, inspects, evaluates, and documents cardiac and vascular allografts. Performs aseptic transfers, tissue receiving and labeling, instrument sterilization, solution preparation, laboratory cleaning, equipment monitoring, material stocking, and batch-record documentation. The role requires strict compliance with SOPs and applicable tissue and manufacturing practices, along with manual dexterity for microsurgical dissection techniques.

The Senior Tax Manager supports worldwide tax provision, U.S. federal and state tax compliance, tax estimates, cash tax forecasting, transfer pricing, R&D credits, tax notices, and global tax calendars. The role also supports SOX controls, tax technology improvements, international tax projects, and cross-functional research. Candidates should have strong tax accounting and compliance expertise, analytical and communication skills, and preferably CPA certification and OneSource Tax Provision experience.

Provides customer service and account support for sales representatives, physicians, and hospitals. Processes tissue orders, customer requests, returns, credits, and GHX orders; creates and maintains customer accounts in SAP; resolves account issues; prepares reports; and manages backorders, sterile sample cycle counts, and consignment inventory for an assigned region.

Leads global biocompatibility, chemical characterization, and toxicology programs for medical devices. Develops biological safety testing strategies, authors assessments and reports, supports regulatory submissions, maintains SOPs and audit readiness, manages CRO and vendor relationships, oversees budgets, and leads cross-functional projects. Manages R&D staff responsible for biological safety and chemical characterization while providing training, technical guidance, and regulatory support across global markets.

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.

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.

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 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.

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.

Lead strategy and day-to-day operations for enterprise infrastructure across on-premises, hybrid and cloud environments. Own availability, capacity, lifecycle, incident response, disaster/cyber recovery, vendor and financial management. Build governance, operating metrics, runbooks, and cross-functional alignment while developing teams and communicating service health and risks to executive leadership.