Company Overview:
Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.
Position Objective:
Utilizes Quality Engineering techniques to ensure that Artivion complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations for calibration during the receipt, use, storage, manufacture, and distribution of products.
Ensures that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner to support Artivion, Inc.
Responsibilities:
Essential functions include, but are not limited to:
- Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and Quality System Regulation/ISO compliance by periodically reviewing specifications for functionality and initiating the required changes, establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures.
- Plan, prepare, and execute calibrations and analyze data to approve equipment and processes used in the testing, processing, storing, and distribution of products.
- Collect, statistically analyze calibration data.
- Assist in the development, implementation, and documentation calibration activities to ensure that the products processed are proven to be reliable, safe, and effective prior to release.
- Effectively complete “other” functions that may be assigned.
Note: Management retains the discretion to add or change the duties of this position at any time to support current business needs.
Qualifications:
- Minimum of a Bachelor’s Degree in engineering field or equivalent experience.
- Minimum of 1-year hands-on calibration experience; preferably in an FDA regulated industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards.
Benefits:
- Comprehensive Medical, Dental, and Vision
- Life Insurance
- Supplemental Benefits
- 401(k) with both Traditional and Roth options available
- Employee Stock Purchase Plan (ESPP)
- 10 Paid Company Holidays
- Competitive PTO plan
- Tuition Reimbursement
Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.
Qualifications Education Required Bachelors or better. Experience Required Hands-on calibration experience Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- Bachelor's degree in engineering or equivalent experience
- At least one year of hands-on calibration experience
- Experience in an FDA-regulated pharmaceutical, biomedical, or medical device industry
- In-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO standards
What We Do
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. Our purpose is to develop simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with diseases of the aorta and deliver breakthrough technologies of unsurpassed quality that have far-reaching impact. Our decades of expertise in treating aortic diseases—coupled with our recent acquisitions and partnerships—have empowered us to offer cardiac and vascular surgeons a suite of aortic-centric solutions such as cryopreserved cardiac and vascular allografts, surgical sealants, prosthetic heart valves, and aortic stents and stent-grafts. Artivion has over 1,250 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.
