{"schemaVersion":"jobsearcher.job.v1","id":"176d76fd6220cafc430372d6","url":"https://jobsearcher.com/jobs/176d76fd6220cafc430372d6","canonicalUrl":"https://jobsearcher.com/jobs/176d76fd6220cafc430372d6","title":"Lead Engineer, Process Optimization","description":"Position Summary\nSenior Engineer, Process Optimization is a key technical leader responsible for developing and driving BioTissue’s Continuous Improvement (CI) program. This expert-level role owns the creation and execution of the 12‑month CI pipeline—including Kaizens, 5S, statistical analysis, training, and other core CI methodologies—and plays a central role in shaping CI culture across the organization. Operating with significant autonomy, this position identifies improvement opportunities through both quantitative analysis and on‑the‑floor observation. The Senior Engineer partners closely with Operations, Engineering, Development, Production, Supply Chain, Distribution, Facilities, IT, and Quality to optimize manufacturing and operational processes, enhance product quality, and strengthen daily operational performance. This role is highly hands‑on and requires strong technical depth, cross‑functional collaboration, and the ability to lead change in a regulated GMP environment.\n\nEssential Duties & Responsibilities\nProcess Optimization & Analysis\n\nAnalyze existing workflows, equipment, and systems to identify bottlenecks, inefficiencies, and improvement opportunities.\n\nConduct root cause analysis (RCA) to resolve production, quality, and operational issues.\n\nIdentify opportunities to reduce scrap, waste, and raw material usage.\n\nGather and translate business requirements into actionable improvement plans.\n\nContinuous Improvement Leadership\n\nDevelop, manage, and execute the 12‑month Continuous Improvement Program plan.\n\nLead CI initiatives using Lean, Six Sigma, and related methodologies (e.g., value stream mapping, 5S, Kaizen).\n\nMentor teams in the application of CI principles, including early product development activities.\n\nDrive change management efforts to ensure adoption and sustainability of improvements.\n\nCross‑Functional Support\n\nPartner with Operations leaders to develop and refine KPIs supporting inventory, productivity, quality, safety, and delivery goals.\n\nSupport ERP/MES end‑users and contribute to system optimization efforts.\n\nCollaborate with Engineering, Manufacturing, Supply Chain, Distribution, Facilities, IT, and QA on cross‑functional improvement projects.\n\nCompliance & Quality\n\nEnsure all CI activities comply with BioTissue’s Quality Management System and applicable regulatory requirements, including cGMP, FDA, ISO, and GTP standards.\n\nTechnical Expertise\n\nSignificant applied Continuous Improvement experience.\n\nStrong understanding of workflow optimization and process engineering.\n\nExperience with automation and AI‑assisted workflows.\n\nProficiency with ERP and MES systems.\n\nStrong troubleshooting and analytical skills.\n\nAdvanced proficiency in Microsoft Excel, Word, PowerPoint, and Outlook.\n\nLeadership & Behavioral Competencies\n\nDemonstrated ability to lead change, remove barriers, and promote CI culture.\n\nStrong communication and collaboration skills across diverse teams.\n\nAbility to coordinate multiple tasks with attention to detail and follow‑through.\n\nTenacious, data‑driven, and proactive in identifying and addressing improvement needs.\n\nRegulatory & Quality Knowledge: Thorough understanding of GTP, cGMP, quality systems, and compliance requirements.\n\nPosition Expertise/Qualifications\n\nBachelor's degree in engineering or similar required.\n\nSix Sigma black belt preferred.\n\n5 years process optimization/industrial engineering experience in a GMP manufacturing environment, preferred.\n\nPhysical Requirements\n\nSedentary work that generally requires sitting and/or standing.\n\n#J-18808-Ljbffr","company":"Biotissue","rawCompany":"biotissue","city":"Doral","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:33:37.710Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.00","title":"Industrial Engineers","slug":"industrial-engineers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Lead Engineer, Process Optimization","description":"Position Summary\nSenior Engineer, Process Optimization is a key technical leader responsible for developing and driving BioTissue’s Continuous Improvement (CI) program. This expert-level role owns the creation and execution of the 12‑month CI pipeline—including Kaizens, 5S, statistical analysis, training, and other core CI methodologies—and plays a central role in shaping CI culture across the organization. Operating with significant autonomy, this position identifies improvement opportunities through both quantitative analysis and on‑the‑floor observation. The Senior Engineer partners closely with Operations, Engineering, Development, Production, Supply Chain, Distribution, Facilities, IT, and Quality to optimize manufacturing and operational processes, enhance product quality, and strengthen daily operational performance. This role is highly hands‑on and requires strong technical depth, cross‑functional collaboration, and the ability to lead change in a regulated GMP environment.\n\nEssential Duties & Responsibilities\nProcess Optimization & Analysis\n\nAnalyze existing workflows, equipment, and systems to identify bottlenecks, inefficiencies, and improvement opportunities.\n\nConduct root cause analysis (RCA) to resolve production, quality, and operational issues.\n\nIdentify opportunities to reduce scrap, waste, and raw material usage.\n\nGather and translate business requirements into actionable improvement plans.\n\nContinuous Improvement Leadership\n\nDevelop, manage, and execute the 12‑month Continuous Improvement Program plan.\n\nLead CI initiatives using Lean, Six Sigma, and related methodologies (e.g., value stream mapping, 5S, Kaizen).\n\nMentor teams in the application of CI principles, including early product development activities.\n\nDrive change management efforts to ensure adoption and sustainability of improvements.\n\nCross‑Functional Support\n\nPartner with Operations leaders to develop and refine KPIs supporting inventory, productivity, quality, safety, and delivery goals.\n\nSupport ERP/MES end‑users and contribute to system optimization efforts.\n\nCollaborate with Engineering, Manufacturing, Supply Chain, Distribution, Facilities, IT, and QA on cross‑functional improvement projects.\n\nCompliance & Quality\n\nEnsure all CI activities comply with BioTissue’s Quality Management System and applicable regulatory requirements, including cGMP, FDA, ISO, and GTP standards.\n\nTechnical Expertise\n\nSignificant applied Continuous Improvement experience.\n\nStrong understanding of workflow optimization and process engineering.\n\nExperience with automation and AI‑assisted workflows.\n\nProficiency with ERP and MES systems.\n\nStrong troubleshooting and analytical skills.\n\nAdvanced proficiency in Microsoft Excel, Word, PowerPoint, and Outlook.\n\nLeadership & Behavioral Competencies\n\nDemonstrated ability to lead change, remove barriers, and promote CI culture.\n\nStrong communication and collaboration skills across diverse teams.\n\nAbility to coordinate multiple tasks with attention to detail and follow‑through.\n\nTenacious, data‑driven, and proactive in identifying and addressing improvement needs.\n\nRegulatory & Quality Knowledge: Thorough understanding of GTP, cGMP, quality systems, and compliance requirements.\n\nPosition Expertise/Qualifications\n\nBachelor's degree in engineering or similar required.\n\nSix Sigma black belt preferred.\n\n5 years process optimization/industrial engineering experience in a GMP manufacturing environment, preferred.\n\nPhysical Requirements\n\nSedentary work that generally requires sitting and/or standing.\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T03:33:37.710Z","dateModified":"2026-07-16T03:33:37.710Z","hiringOrganization":{"@type":"Organization","name":"Biotissue","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Doral","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"176d76fd6220cafc430372d6"},"url":"https://jobsearcher.com/jobs/176d76fd6220cafc430372d6"}}