Industrial EngineerDepartment: Manufacturing
Employment Type: Full Time
Location: Burlington, MA
Compensation: $90,000 - $115,000 / year
DescriptionWhat we're looking for: The Industrial Engineer is responsible for improving manufacturing operations through the application of
industrial engineering principles, Lean manufacturing methodologies, and data-driven decision making. This role focuses on optimizing manufacturing processes, labor utilization, material flow, production capacity, and facility layout to improve safety, quality, delivery, and cost. The Industrial Engineer works cross-functionally with Manufacturing, Quality, Supply Chain, Engineering, and Operations to identify improvement opportunities, implement sustainable solutions, and support operational excellence in a regulated medical device manufacturing environment.
Keys to success include curiosity, initiative, and a drive to unlock better systems and workflows, ultimately supporting optimal performance. Our ideal candidate is deeply positive, process-minded, and highly detailed, viewing this role as a vehicle to continually foster a culture of excellence. How You'll Drive Impact:Manufacturing Process Improvement:- Analyze manufacturing processes to improve productivity, quality, safety, and efficiency.
- Conduct time studies, work measurement, and labor utilization analyses to establish standard
work and optimize staffing levels. - Lead continuous improvement initiatives utilizing Lean Manufacturing principles, including Value
Stream Mapping, 5S, Standard Work, Visual Management, Kanban, and Kaizen events. - Identify and eliminate waste while improving workflow, throughput, and manufacturing
performance. - Develop and monitor key manufacturing metrics to drive operational improvements.
Production & Capacity Planning:- Evaluate production capacity and develop recommendations to support changing production demands.
- Perform line balancing and workflow optimization to maximize labor and equipment utilization.
- Analyze bottlenecks and recommend improvements to increase throughput.
- Support facility layout planning and material flow improvements.
- Develop labor standards and assist Operations with production planning.
Manufacturing Support:- Partner with Manufacturing Engineering to improve existing manufacturing processes and support new product introductions.
- Support root cause investigations and implement corrective actions using structured problem-
solving methodologies. - Collaborate with Quality to implement and verify CAPA activities.
- Identify and lead cost reduction initiatives through process optimization and waste elimination.
- Evaluate equipment, tooling, fixtures, and automation opportunities to improve operational
efficiency.
Data Analysis: - Collect, analyze, and present manufacturing performance data.
- Develop dashboards and reports tracking productivity, labor efficiency, OEE, scrap, cycle time, and throughput.
- Perform statistical analyses to identify trends and quantify improvement opportunities.
- Present recommendations to leadership using data-driven analyses.
Documentation & Compliance: - Develop and maintain manufacturing documentation, including standard work, process maps, work instructions, labor standards, and workflow diagrams.
- Support process validation activities as required.
- Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and internal quality procedures.
- Participate in internal and external audits.
Cross-Functional Collaboration: - Work closely with Manufacturing, Engineering, Supply Chain, Quality, and Operations to achieve production objectives.
- Train manufacturing personnel on standardized work and Lean methodologies.
- Participate in cross-functional improvement teams supporting strategic initiatives.
- Promote a culture of continuous improvement throughout the organization.
What You'll Bring:- Bachelor's degree in Industrial Engineering or related engineering discipline.
- 2-5 years of experience in manufacturing, industrial engineering, or operations engineering.
- Experience with Lean Manufacturing and continuous improvement methodologies.
- Experience conducting time studies, labor analysis, line balancing, and workflow optimization.
- Strong analytical and problem-solving skills.
- Proficiency with Microsoft Excel and data analysis tools.
- Experience developing manufacturing KPIs and performance metrics.
- Familiarity with root cause analysis techniques (5 Whys, Fishbone, A3, 8D).
- Excellent communication and project management skills.
Preferred: - Experience in medical device or other regulated manufacturing environments.
- Lean Six Sigma Green Belt or Black Belt certification.
- Experience with MES systems (Tulip preferred).
- Familiarity with process validation (IQ/OQ/PQ).
- Knowledge of statistical process control (SPC).
- Experience with facility layout planning and material flow analysis.
- Experience using Power BI, Minitab, SQL, or Python for data analysis.
