Manager, Technical Process

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion's four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com .

Manages Tissue Processing Lab personnel to ensure that allografts meet all specifications, and that the lab complies with quality and regulatory requirements. Leads process improvements and projects that improve yield rates, reduce unit costs, and improve general throughput. Responsible for capital equipment budgeting, asset generation, purchase, installation, and validation activities.

1. Scheduling of daily laboratory staff to ensure that the goals of the company are met.
2. Lead initiatives within TPL to ensure accurate project prioritization and ensure engineering activities to support equipment qualifications and validations are achieved.
3. Manage staff to ensure all tissue is processed within specifications and quality is maintained.
4. Manage staff to perform all tasks for efficient operation of the laboratory.
5. Manage, schedule, and perform training of technicians to achieve proficiency.
6. Perform time management of TPL staff including timesheets, PTO requests, and call pay to ensure accuracy and prompt action.
7. Evaluate performance of team leaders, trainers, and technicians through direct observation to ensure consistency and tissue quality.
8. Recommend promotions and raises of team leaders, trainers, and technicians.
9. Implementation of new and revised documents and procedures.
10. Work with trainers and team leaders to create and implement new procedures for improvement of current processes or addition of new ones.
11. Evaluate yield improvement opportunities and develop an actionable plan of improvement.
12. Assist in the recruiting, screening, interviewing, hiring, counseling and termination of TPL staff.
13. Review tissue records, equipment monitoring records, autoclave log, cryopreservation cycles, and antibiotic intermediate documentation to assure lab compliance.
14. Assist with investigations related to processing non-conformances, environmental actions, and complaints. Assist with complaint sample reviews as needed.
15. Coordinate MRB meetings as needed.
16. Assist with non-conformance verifications and tracking.
17. Assist with coordinating staff meetings.
18. Responsible for Capital budgeting related to TPL equipment.
19. Coordinates and leads Change Control activities associated with equipment installation/decommissioning or process improvement activities.
20. Perform duties of technicians as needed.
21. Other responsibilities as assigned.
22. Laboratory is staffed adequately on a daily basis to ensure goals of the company are met.
23. All tissue is processed within specifications.
24. Completion of training requirements for technicians.
25. Reduction of laboratory errors and improvement of tissue yields.

Qualifications:

• Bachelor's degree in engineering or related field required. Master's degree is preferred but not required.
• 3 years people leader experience desired. Tissue processing/medical device/pharmaceutical/biotech manufacturing/engineering experience is preferred but not required.
• Excellent verbal and written communication skills
• Can give audience appropriate messaging
• Give regular feedback to employees and maintain standards through accountability
• Collaborates well with all supporting departments
• Capable of direct and indirect influence to meet set objectives
• Capable and comfortable with making timely decisions related to people and processes
• Strong analytical skills to develop solutions to issues
• Contingency planning skills are a plus.