Lead Engineer, Process Optimization

Lead Engineer, Process OptimizationThe Lead 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 Lead 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.Essential Duties & ResponsibilitiesProcess Optimization & AnalysisAnalyze existing workflows, equipment, and systems to identify bottlenecks, inefficiencies, and improvement opportunities.Conduct root cause analysis (RCA) to resolve production, quality, and operational issues.Identify opportunities to reduce scrap, waste, and raw material usage.Gather and translate business requirements into actionable improvement plans.Continuous Improvement LeadershipDevelop, manage, and execute the 12-month Continuous Improvement Program plan.Lead CI initiatives using Lean, Six Sigma, and related methodologies (e.g., value stream mapping, 5S, Kaizen).Mentor teams in the application of CI principles, including early product development activities.Drive change management efforts to ensure adoption and sustainability of improvements.Cross-Functional SupportPartner with Operations leaders to develop and refine KPIs supporting inventory, productivity, quality, safety, and delivery goals.Support ERP/MES end-users and contribute to system optimization efforts.Collaborate with Engineering, Manufacturing, Supply Chain, Distribution, Facilities, IT, and QA on cross-functional improvement projects.Compliance & QualityEnsure all CI activities comply with BioTissue's Quality Management System and applicable regulatory requirements, including cGMP, FDA, ISO, and GTP standards.Leadership & Behavioral CompetenciesDemonstrated ability to lead change, remove barriers, and promote CI culture.Strong communication and collaboration skills across diverse teams.Ability to coordinate multiple tasks with attention to detail and follow-through.Tenacious, data-driven, and proactive in identifying and addressing improvement needs.Regulatory & Quality KnowledgeThorough understanding of GTP, cGMP, quality systems, and compliance requirements.Position Expertise/QualificationsBachelor's degree in engineering or similar required.Six Sigma black belt preferred5 years process optimization/industrial engineering experience in a GMP manufacturing environment, preferred.Physical RequirementsSedentary work that generally requires sitting and/or standing