Calibration Engineer I (On-Site | Austin, TX)

Artivion, Inc.; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Plan

ESPP

Paid Holidays

PTO

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin, TX seeks a Quality Engineer to lead calibration activities, ensure compliance with GMP, QSR, and ISO standards, and support reliable product testing and release. The role emphasizes data-driven decision making and cross-functional collaboration.

The successful candidate will have a bachelor’s degree in engineering and at least 1 year of calibration experience in a regulated environment, contributing to safe, effective medical devices.

Qualifications

• Bachelor’s Degree in engineering or equivalent experience.
• 1+ year hands-on calibration experience; FDA-regulated industry preferred; knowledge of GMP, QSR, and ISO.

Responsibilities

• Plan, prepare, and execute calibrations and analyze data for approvals.
• Collect and statistically analyze calibration data.
• Develop and document calibration activities to ensure reliability and safety.
• Support adherence to Quality System Regulations/ISO across processes.
• Perform any other duties as assigned.

Skills

Calibration

Quality engineering

Regulatory knowledge

Data analysis

Education

Bachelor’s degree in engineering

Job description

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.

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.