Manufacturing Engineer; Continuous Improvement​/Lean Operations

Job Title:
Manufacturing Engineer (Continuous Improvement / Lean Operations)

Job Description

The Manufacturing Engineer will drive continuous improvement initiatives within a regulated, high-mix, low-volume manufacturing environment. This role focuses on Lean manufacturing, Lean Six Sigma, 5S, industrial engineering, labor and process analysis, waste reduction, yield improvement, and overall manufacturing efficiency. The engineer collaborates closely with Manufacturing, Operations, Quality, R&D, and other cross‑functional teams to identify process constraints, investigate manufacturing issues, implement corrective actions, and sustain measurable improvements.

This is a hands‑on position that requires regular support of production activities within a Class 7 cleanroom.

• Lead continuous improvement initiatives using data-driven problem-solving methods to enhance manufacturing performance.
• Apply Lean Six Sigma and 5S principles to improve manufacturing flow, productivity, efficiency, safety, and workplace organization.
• Conduct labor time studies, process studies, and capacity analyses to establish standards and identify improvement opportunities.
• Develop and analyze process flow diagrams to evaluate bottlenecks, constraints, and manufacturing inefficiencies.
• Perform line balancing and evaluate value-added versus non-value-added activities to optimize production lines.
• Use Value Stream Mapping, spaghetti diagrams, and other Lean tools to identify and reduce waste.
• Lead initiatives focused on improving throughput, productivity, yield, and overall manufacturing efficiency.
• Analyze labor performance against established standards, identify significant variances, and recommend corrective actions.
• Perform root cause and corrective action investigations using tools such as fishbone diagrams, the 6
  
  Ms, and 5 Whys.
• Support RCCA and CAPA activities, including implementation and follow-through of corrective and preventive actions.
• Support process and equipment qualification activities, including IQ, OQ, and PQ.
• Drive capital equipment requests and support equipment qualification, implementation, and integration into manufacturing operations.
• Analyze mechanical designs, technical drawings, measurement systems, and manufacturing requirements to ensure robust production processes.
• Partner with Design Engineering and Manufacturing to incorporate Design for Manufacture and Assembly and cost considerations into product and process decisions.
• Lead process and product investigations and implement manufacturing fixes, modifications, and design enhancements.
• Ensure process and design changes are properly documented and comply with applicable quality and regulatory requirements.
• Create and update technical documentation, work instructions, process flow diagrams, control plans, and related manufacturing records.
• Support daily manufacturing operations within a Class 7 cleanroom, including adherence to gowning and cleanliness requirements.
• Build effective working relationships with internal teams and external partners to support operational excellence.
• Perform other related duties as assigned to support manufacturing engineering and operational goals.

• At least 5 years of manufacturing engineering experience.
• Demonstrated experience with Lean manufacturing, continuous improvement, 5S, and waste reduction.
• Hands‑on experience planning or leading continuous improvement events and sustaining implemented improvements.
• Practical experience conducting labor time studies, process flow analysis, bottleneck analysis, and line balancing.
• Proven experience improving throughput, productivity, yield, or manufacturing efficiency.
• Experience performing root cause investigations and implementing corrective actions.
• Working…