{"schemaVersion":"jobsearcher.job.v1","id":"fdc8015f42a695c82d623e48","url":"https://jobsearcher.com/jobs/fdc8015f42a695c82d623e48","canonicalUrl":"https://jobsearcher.com/jobs/fdc8015f42a695c82d623e48","title":"Process Engineer II","description":"Company Overview\n\nHeadquartered 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.\n\nPosition Objective:\n\nResponsible 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.\n\nResponsibilities:\n\nProcess Engineering Support:\n\nOwn manufacturing processes to ensure stable, efficient, and compliant production in an FDA/ISO-regulated environment.\nProvide 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.\nDevelop and maintain manufacturing documentation (SOPs, work instructions, drawings, etc.), ensuring audit readiness and traceability.\nLead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes.\nPartner with Quality to resolve nonconformances, drive CAPA to resolve issues and prevent recurrence\nProvide technical ownership for suppliers, including component/process qualification, issue resolution, and driving improvements in supplier quality and performance.\nCoordinate Engineering Change Notices (ECN) with managerial oversight for process & equipment changes and process impact of material changes.\nAbility to read and update CAD drawings, Solid Model assemblies, and machine schematics to troubleshoot problems and implement solutions\nPerform additional duties as assigned by Manager.\n\nContinuous improvement:\n\nIdentify improvement opportunities through data analysis, operator feedback, and observation; implement data-driven improvements to enhance yield, throughput, and uptime.\nMonitor and improve performance using SPC and capability analysis (Cp/Cpk); establish and maintain process control limits.\n\nNew Process/Product Implementation:\n\nSupport equipment and tooling selection, qualification, and implementation, including automation where applicable.\nLead design transfer and new product introduction (NPI), ensuring manufacturability, scalability, and alignment between R&D and operations.\nProvides 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.\n\nOther responsibilities as assigned.\n\nQualifications:\n\nRequired:\n\nBachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering).\n2-5 years of medical device, tissue product, or related engineering experience (1-3 years with Masters in Engineering).\nData-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).\nProcess Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.\nCross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.\n\nRequired:\n\nCNC / Machining Knowledge: basic understanding of CNC milling, turning, lathes, lapping, multi-axis machining, etc. is preferred\nCAD/CAM & Programming Proficiency: basic understanding of CAM Software (Mastercam), how to generate/optimize toolpaths, and machine code (G-code)\n\nBenefits:\n\nComprehensive Medical, Dental, and Vision\nLife Insurance\nSupplemental Benefits\n401(k) with both Traditional and Roth options available\nEmployee Stock Purchase Plan (ESPP)\n10 Paid Company Holidays\nCompetitive PTO plan\nTuition Reimbursement\n\nEqual Employment Opportunity Employer (EEO):\nWe 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.\n\nEqual Opportunity Employer\nThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.","company":"Austin","rawCompany":"austin","city":"Austin","state":"TX","isRemote":false,"isActive":false,"createdAt":"2026-08-28T10:18:26.450Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer II","description":"Company Overview\n\nHeadquartered 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.\n\nPosition Objective:\n\nResponsible 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.\n\nResponsibilities:\n\nProcess Engineering Support:\n\nOwn manufacturing processes to ensure stable, efficient, and compliant production in an FDA/ISO-regulated environment.\nProvide 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.\nDevelop and maintain manufacturing documentation (SOPs, work instructions, drawings, etc.), ensuring audit readiness and traceability.\nLead process validation (IQ/OQ/PQ), PFMEA, and risk management to ensure robust and compliant processes.\nPartner with Quality to resolve nonconformances, drive CAPA to resolve issues and prevent recurrence\nProvide technical ownership for suppliers, including component/process qualification, issue resolution, and driving improvements in supplier quality and performance.\nCoordinate Engineering Change Notices (ECN) with managerial oversight for process & equipment changes and process impact of material changes.\nAbility to read and update CAD drawings, Solid Model assemblies, and machine schematics to troubleshoot problems and implement solutions\nPerform additional duties as assigned by Manager.\n\nContinuous improvement:\n\nIdentify improvement opportunities through data analysis, operator feedback, and observation; implement data-driven improvements to enhance yield, throughput, and uptime.\nMonitor and improve performance using SPC and capability analysis (Cp/Cpk); establish and maintain process control limits.\n\nNew Process/Product Implementation:\n\nSupport equipment and tooling selection, qualification, and implementation, including automation where applicable.\nLead design transfer and new product introduction (NPI), ensuring manufacturability, scalability, and alignment between R&D and operations.\nProvides 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.\n\nOther responsibilities as assigned.\n\nQualifications:\n\nRequired:\n\nBachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering).\n2-5 years of medical device, tissue product, or related engineering experience (1-3 years with Masters in Engineering).\nData-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).\nProcess Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.\nCross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.\n\nRequired:\n\nCNC / Machining Knowledge: basic understanding of CNC milling, turning, lathes, lapping, multi-axis machining, etc. is preferred\nCAD/CAM & Programming Proficiency: basic understanding of CAM Software (Mastercam), how to generate/optimize toolpaths, and machine code (G-code)\n\nBenefits:\n\nComprehensive Medical, Dental, and Vision\nLife Insurance\nSupplemental Benefits\n401(k) with both Traditional and Roth options available\nEmployee Stock Purchase Plan (ESPP)\n10 Paid Company Holidays\nCompetitive PTO plan\nTuition Reimbursement\n\nEqual Employment Opportunity Employer (EEO):\nWe 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.\n\nEqual Opportunity Employer\nThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of Labor.","datePosted":"2026-08-28T10:18:26.450Z","dateModified":"2026-08-28T10:18:26.450Z","hiringOrganization":{"@type":"Organization","name":"Austin","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Austin","addressRegion":"TX","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fdc8015f42a695c82d623e48"},"url":"https://jobsearcher.com/jobs/fdc8015f42a695c82d623e48"}}