Process Engineer III - Controls Engineer

On-X Life Technologies, Inc.; Austin (TX); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Comprehensive Medical, Dental, and Vis

Life Insurance

Supplemental Benefits

401(k) with both Traditional and Roth

Employee Stock Purchase Plan (ESPP)

10 Paid Company Holidays

Competitive PTO plan

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin, TX seeks a Process Engineer to support the Coating manufacturing area, drive process improvements, and ensure SOP compliance across operations.

The role collaborates with quality, regulatory, and operations to optimize yield, reduce cycle times, and validate new equipment through IQ/OQ/PQ, while developing and updating manufacturing documentation.

Qualifications

• Master's degree with 2-4 years of experience or bachelor's with 4-6 years.
• Engineering degree (Electrical, Mechanical, Computer, Chemical).
• Data-driven problem solving with SPC knowledge.
• Lean principles; cycle time, throughput, yield improvements.
• Cross-functional collaboration; train operators and implement new processes.

Responsibilities

• Collaborates with quality and operations to specify materials and parts.
• Troubleshoots equipment and processes; orders parts as needed.
• Revises equipment drawings using CAD software.
• Coordinates ECNs for design changes (no managerial oversight).
• Equipment validations including IQ, OQ, and PQ.
• Maintains and assists in development of PLC controlled processes.
• Evaluates parameters for OEM equipment software.
• Leads tasks or sub-projects within major product/process improvements.
• Supports new equipment start-up, debug and validation.
• Develops and documents operations procedures and SOPs.
• Coordinates product and packaging distribution and shelf-life tests.
• Assist in audits and CAPA investigations as assigned.

Skills

Data-Driven Problem Solving

Lean Manufacturing

Cross-Functional Collaboration

Process Optimization

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Tools

CAD software

PLC/SCADA familiarity

Job description

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 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 and 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 processes.
• Reduction of manufacturing errors and improvement of yields and cycle times.
• Successful completion of audits.
• Provide knowledge and feedback to the production team for the successful implementation of new processes or equipment.
• Addressing supplier continuity issues to prevent product run-out.
• Continuous Process Improvement.
• Other responsibilities as assigned.

Qualifications

• Master's degree with 2-4 years of equivalent experience, or bachelor's degree with 4-6 years of equivalent experience.
• 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).
• Process Optimization / Lean Manufacturing: Demonstrated execution of lean principles, cycle time and throughput improvement, yield improvement, and workflow optimization.
• Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory, and management teams; train operators and implement new processes.

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.

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.