Job Description

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 our Coating manufacturing area. 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 develop 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

• Collaborates with quality and operations to determine and develop needed materials and/or parts specifications.
• Troubleshoots equipment and processes through physical inspection/diagnosing of parts. Orders replacement parts as needed.
• Revises equipment and part drawings using CAD software.
• Coordinates Engineering Change Notices for design changes, including materials and process changes. (no managerial oversight)
• Equipment validations including IQ OQ and PQ
• Maintains and assists in development of PLC controlled processes. Evaluates and implements appropriate parameters for OEM equipment software.
• Leads tasks or sub-projects within major product and process improvement initiatives.
• Provides technical support when dealing with suppliers of key components and equipment.
• Provides engineering support for new equipment start-up, debug and process validation. As required, develops, and conducts process evaluations and validations under guidance of senior engineers and quality engineering.
• Incorporates best practices in the creation and improving of Operations documentation.
• Coordinates product and packaging distribution and shelf-life tests.
• Assist in audit deliverables and/or CAPA investigations and deliverables as assigned by management.
• Successful implementation of new products and processe
• Reduction of manufacturing errors and improvement of yields and cycle times.
• Successful completion of
• Provide knowledge and feedback to the production team for the successful implementation of new processes or
• Addressing supplier continuity issues to prevent product run-out.
• Continuous Process

Other responsibilities as assigned.

Qualifications

• Degree in Engineering (Electrical, Mechanical, Computer, Chemical)
• 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.
• Master’s degree with 3 years of equivalent experience, or bachelor’s degree with 5 years of equivalent experience
• Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.

Preferred Experience:

• Medical Device experience or experience working in a regulated environment
• Experience designing, developing and implementing PLC DCS and SCADA systems
• Experience creating and maintaining control logic, function blocks, and HMI interfaces
• System integration across electrical, mechanical, and software domains
• Experience specifying sensors, actuators, drives, and control hardware
• Distributed control systems
• Data flow analysis
• Familiarity with Computer Aided Design (CAD)

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.