Senior Manufacturing Engineer - Lean & Quality Leadership

L&T Technology Services; Draper (UT); On-site; USD 85,000 - 125,000; Full time

Job summary

L&T Technology Services in Draper, Utah seeks a Senior Manufacturing Engineer to lead process improvements in a highly regulated medical device environment, focusing on implantable components and sustaining manufacturing excellence.

The role emphasizes Lean, CAPA, DOE, SPC, process validation, equipment qualification, and cross-functional leadership to drive quality, yield, and cost reductions while ensuring regulatory compliance.

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical field with approximately 4+ years of relevant industry experience.
• Master's degree with approximately 3+ years of relevant experience may also be considered.
• Strong experience in manufacturing or process engineering.
• Experience working in an FDA-regulated manufacturing environment.
• Knowledge of quality systems, CAPA, nonconformance investigations, and root-cause analysis.
• Experience with process validation and equipment qualification, including IQ/OQ/PQ.
• Knowledge of SPC, DOE, process capability, and statistical analysis.
• Experience with Lean Manufacturing, Six Sigma, or continuous improvement methodologies.
• Strong problem-solving, analytical, communication, and project-management skills.
• Ability to work independently and make sound engineering decisions in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office, including Excel, PowerPoint, and Project.

Responsibilities

• Lead manufacturing improvement initiatives focused on yield improvement, process capability, capacity expansion, cost reduction, and process robustness.
• Identify and implement opportunities to optimize manufacturing processes using Lean Manufacturing, continuous improvement, structured problem-solving, and statistical methods.
• Serve as a technical subject matter expert for manufacturing processes, equipment, tooling, fixtures, and production technologies.
• Lead investigations involving CAPAs, nonconformances, process deviations, audit observations, and quality issues.
• Apply root-cause analysis, SPC, DOE, process capability analysis, and statistical techniques to improve manufacturing performance.
• Design and execute engineering studies, experiments, process validations, and equipment qualifications.
• Develop protocols, analyze results, prepare technical reports, and provide data-driven recommendations.
• Support the introduction of new products, equipment, automation, manufacturing technologies, and process improvements.
• Ensure manufacturing processes and equipment meet quality, safety, performance, and regulatory requirements.
• Lead cross-functional projects in collaboration with Operations, Quality, Supply Chain, Maintenance, and Engineering teams.
• Provide technical direction, mentoring, and training to engineers and technicians.
• Support new product transfers, equipment implementation, change control, risk management, and manufacturing technology integration.
• Develop and maintain manufacturing documentation, work instructions, procedures, training materials, and engineering records.
• Support internal audits, regulatory inspections, and quality-system compliance activities.
• Work independently during second-shift manufacturing operations and provide technical support with limited on-shift engineering resources.

Skills

Process improvement

Statistical analysis

Process validation

Equipment qualification

CAPA

Lean Manufacturing

Yield improvement

SPC

DOE

Six Sigma

Continuous improvement

Cross-functional leadership

Problem solving

Education

Bachelor's degree in Engineering or Science

Master's degree considered

Tools

Microsoft Office

Excel

PowerPoint

Project

Job description

L&T Technology Services in Draper, Utah seeks a Senior Manufacturing Engineer to lead process improvements in a highly regulated medical device environment, focusing on implantable components and sustaining manufacturing excellence.

The role emphasizes Lean, CAPA, DOE, SPC, process validation, equipment qualification, and cross-functional leadership to drive quality, yield, and cost reductions while ensuring regulatory compliance.