Lean Engineer

Beta Bionics•Irvine, CA

1d•Onsite

About The Position

Beta Bionics is a medical technology company focused on diabetes management solutions, including the iLet Bionic Pancreas. The Lean Engineer applies Lean manufacturing principles and data-driven methods to improve safety, quality, delivery, cost, and productivity across manufacturing operations. The role conducts time studies, establishes standard work, balances production lines, develops staffing and capacity models, and works directly on the production floor with cross-functional teams to identify waste and address constraints. It also supports real-time resource allocation, line audits, implementation of improvements, and employee training to sustain results. This is a full-time, onsite position with regular presence on the manufacturing floor. The schedule may need to adjust to support multiple shifts, time studies, audits, training, and improvement implementation; occasional overtime, weekend work, or off-shift coverage may be required. The role works in office, production, laboratory, clean-room, and warehouse environments, where personal protective equipment may be required. Travel may be up to 5% depending on business needs.

Requirements

Strong knowledge of Lean manufacturing principles, waste elimination, continuous improvement, and production flow.
Demonstrated ability to perform time studies, work measurement, line balancing, capacity analysis, and labor planning.
Ability to translate production data and floor observations into practical, measurable improvements.
Strong analytical, root cause analysis, statistical, project-management, and problem-solving skills.
Effective communication, training, facilitation, coaching, change-management, and cross-functional collaboration skills.
Working knowledge of quality systems and regulatory requirements in a regulated manufacturing environment.
Proficiency in Microsoft Excel and data-analysis tools.
Ability to work independently, maintain a strong production-floor presence, and adapt to changing production demands.
Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, Operations, or a related field, or an equivalent combination of education and relevant experience.
3–5 years of experience in manufacturing engineering, industrial engineering, operational excellence, or continuous improvement.
Hands-on experience conducting time studies, balancing production lines, developing staffing models, and implementing standardized work.
Ability to adjust the schedule to support multiple shifts, time studies, audits, training, and improvement implementation; occasional overtime, weekend work, or off-shift coverage may be required.

Nice To Haves

Experience in the medical device industry or another regulated industry.
Lean Six Sigma certification, preferably Green Belt or higher.
Experience with Minitab, Power BI, ERP, or Manufacturing Execution Systems.
Experience applying Lean and Six Sigma methods to measurable improvement projects and training or facilitating teams.
Experience with FDA, ISO 13485, GMP, or similar quality-system requirements.

Responsibilities

Conduct time and motion studies to establish cycle times, takt-time requirements, labor standards, and production capacity.
Analyze work content, demand, staffing, and constraints to balance production lines.
Monitor real-time output, work-in-process, downtime, attendance, and bottlenecks, and partner with production leaders to relocate labor and resources according to business priorities.
Develop and improve line layouts, workstation configurations, standardized work, visual controls, and ergonomic methods.
Conduct routine line audits focused on standardized work, 5S, staffing, material flow, productivity, and process discipline; document findings and track corrective actions to closure.
Lead or support Lean improvement activities using value-stream mapping, Kaizen, 5S, waste analysis, standard work, visual management, and setup reduction.
Analyze cycle time, throughput, labor efficiency, yield, scrap, downtime, and Overall Equipment Effectiveness (OEE) to identify trends and improvement opportunities.
Apply Lean Six Sigma methods, including DMAIC, root cause analysis, and statistical analysis, to resolve recurring issues and reduce variation.
Develop training materials and provide hands-on training and coaching on standard work, Lean tools, and new processes; verify training effectiveness and sustained adoption.
Partner with Quality and Engineering to assess, document, approve, and implement improvements in accordance with the Quality Management System.
Support new product introductions, ramp-up, and process transfers.
Maintain project plans, action logs, and benefit tracking, and communicate progress, risks, and results to stakeholders and management.
Perform other duties as assigned.