Lead Engineer, Process Optimization

Position Summary

The 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.

Essential Duties & Responsibilities

• Analyze 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.
• Develop, 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.
• Partner 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.
• Ensure all CI activities comply with BioTissue’s Quality Management System and applicable regulatory requirements, including cGMP, FDA, ISO, and GTP standards.

Skills & Abilities

• Significant applied Continuous Improvement experience.
• Strong understanding of workflow optimization and process engineering.
• Experience with automation and AI-assisted workflows.
• Proficiency with ERP and MES systems.
• Strong troubleshooting and analytical skills.
• Advanced proficiency in Microsoft Excel, Word, PowerPoint, and Outlook.

Leadership & Behavioral Competencies

• Demonstrated 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 Knowledge

• Thorough understanding of GTP, cGMP, quality systems, and compliance requirements.

Position Expertise/Qualifications

• Bachelor's degree in engineering or similar required.
• Six Sigma black belt preferred.
• 5 years process optimization/industrial engineering experience in a GMP manufacturing environment, preferred.

Physical Requirements

Sedentary work that generally requires sitting and/or standing.