Process Engineer III - Machine Shop Support

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 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

Position Objective

Responsible for providing process engineering support for the Machine Shop and act as a backup to any/all other manufacturing departments. Supports manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. Initiates process improvement initiatives to improve the efficiency of current manufacturing processes, as well as developing new processes to improve manufacturing efficiency. Supports new product launches by collaborating with other functional areas and providing process engineering expertise during the implementation of processes or equipment.

Responsibilities

Process Engineering Support:

• Own manufacturing processes to ensure stable, efficient, and compliant production in an FDA/ISO-regulated environment.
• Provide production support by troubleshooting processes and equipment, performing root cause analysis, and delivering technical leadership and training to production teams to ensure effective execution and sustainment.
• Incorporates best practices in the creation and improving of Operations documentation.
• Lead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes.
• Partner with Quality to resolve nonconformance, drive CAPA to resolve issues and prevent recurrence.
• Provide technical ownership for suppliers, including component/process qualification, issue resolution, and driving improvements in supplier quality and performance.
• Maintains and assists in development of PLC controlled processes. Evaluates and implements appropriate parameters for OEM equipment software.
• Coordinate Engineering Change Notices (ECN) for process & equipment changes and process impact of material changes.
• Revises equipment and part drawings using CAD software
• Assist in audit deliverables and/or CAPA investigations and deliverables as assigned by management.
• Addressing supplier continuity issues to prevent product run-out.
• Perform additional duties as assigned by Manager.

Continuous improvement:

• Leads tasks or sub-projects.
• Identify improvement opportunities through data analysis, operator feedback, and observation; implement data-driven improvements to enhance yield, throughput, and uptime.
• Monitor and improve performance using SPC and capability analysis (Cp/Cpk); establish and maintain process control limits.

New Process/Product Implementation:

• Support equipment and tooling selection, qualification, and implementation, including automation where applicable.
• Lead design transfer and new product introduction (NPI), ensuring manufacturability, scalability, and alignment between R&D and operations.
• Provides engineering support for new equipment start-up, debug and process validation. As required, conducts process evaluations and validations under guidance of senior engineers and Quality Engineering.

Key Results Expected

1. Successful implementation of new products and processe.
2. Reduction of manufacturing errors and improvement of yields and cycle times.
3. Successful completion of audits.
4. Provide knowledge and feedback to the production team for the successful implementation of new processes or equipment.
5. Addressing supplier continuity issues to prevent product run-out.
6. Continuous Process Improvement.
7. Seamless equipment validation and execution of the qualification processes.

Qualifications

Required:

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering).
• 4-6 years of medical device, tissue product, or related engineering experience (2-4 years with Masters in Engineering).
• Data-Driven Problem Solving: Demonstrated understanding of problem-solving tools including; root cause analysis (5-why, fishbone) and Statistical process control (SPC), etc.
• Process Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.
• Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.
• Knowledge of how to conceptualize process workflows.
• Ability to follow, execute, convey moderately complex instructions to make engineering updates.
• Demonstrates the ability to manage multiple tasks to completion.
• Demonstrates the ability to analyze complex problems and develop practical solutions.
• Demonstrates good verbal and written communication skills.
• Demonstrates attention to detail and the ability to produce results.
• Is considered emerging subject matter expert and resource for junior level employees.
• Demonstrates good interpersonal skills in a team environment.

Preferred Experience:

• CNC / Machining Knowledge: basic understanding of CNC milling, grinding, turning, lathes, lapping, multi-axis machining, etc.
• CAD/CAM & Programming Proficiency: basic understanding of CAM Software (Mastercam), how to generate/optimize tool paths, and machine code (G-code).

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.