Process Engineer II

Austin, Inc.; Austin (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision

Life Insurance

401(k) with Traditional and Roth

ESPP

Paid Holidays

PTO

Tuition Reimbursement

Job summary

Artivion, Inc. in Austin is seeking a Process Engineer to provide engineering support for the Machine Shop within an FDA/ISO-regulated manufacturing environment.

You will drive process improvements, develop SOPs and work instructions, and collaborate with quality and R&D to sustain production and support new product launches. Responsibilities include leading IQ/OQ/PQ validations, PFMEA, CAPA resolution, and CAD/drawing updates.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field).
• 2–5 years in medical device or related engineering experience (1–3 years with Masters).
• Data-driven problem solving with SPC and root-cause analysis.
• Lean manufacturing / process optimization experience.
• Cross-functional collaboration with operators, quality, regulatory and management.

Responsibilities

• Own manufacturing processes in FDA/ISO environment, ensuring stability and compliance.
• Troubleshoot processes/equipment, perform root-cause analysis, and train production teams.
• Develop and maintain SOPs, work instructions, drawings, and audit readiness.
• Lead IQ/OQ/PQ validations, PFMEA, and risk management activities.
• Coordinate with Quality to resolve nonconformances and drive CAPA.

Skills

Data-Driven Problem Solving

Process Optimization / Lean Mfg.

Cross-Functional Collaboration

Education

Bachelor's degree in Engineering

Tools

CAD/CAM & Programming Proficiency

CNC / Machining Knowledge

Job description

• On-site
• Full-Time
• Requisition #: PROCE002520

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 1,400 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 atwww.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.
• Develop and maintain manufacturing documentation (SOPs, work instructions, drawings, etc.), ensuring audit readiness and traceability.
• Lead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes.
• Partner with Quality to resolve nonconformances, 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.
• Coordinate Engineering Change Notices (ECN) with managerial oversight for process & equipment changes and process impact of material changes.
• Ability to read and update CAD drawings, Solid Model assemblies, and machine schematics to troubleshoot problems and implement solutions
• Perform additional duties as assigned by Manager.
• 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.

Other responsibilities as assigned.

Qualifications

Required

• Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering).
• 2-5 years of medical device, tissue product, or related engineering experience (1-3 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 Typically requires 2-5 years of medical device, tissue product or related engineering experience (1-3 years with Masters in Engineering).
• 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.

Required

• CNC / Machining Knowledge: basic understanding of CNC milling, turning, lathes, lapping, multi-axis machining, etc. is preferred
• CAD/CAM & Programming Proficiency: basic understanding of CAM Software (Mastercam), how to generate/optimize toolpaths, and machine code (G-code)
• Comprehensive Medical, Dental, and Vision
• Life Insurance
• 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.

Equal Opportunity Employer

This 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.