Senior Manufacturing Engineer

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

We are looking for an experienced Senior Manufacturing Engineer to join a highly regulated medical device manufacturing environment. This role will provide technical leadership in improving and sustaining manufacturing processes for critical implantable components.

The ideal candidate will have strong experience in manufacturing process improvement, statistical analysis, process validation, equipment qualification, CAPA, and Lean Manufacturing, along with the ability to lead cross-functional projects and solve complex technical challenges independently.

Key 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.

Required 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 a 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.

Preferred Qualifications

• Medical device manufacturing experience, particularly with implantable products or components.
• Experience with FDA regulations and quality-system requirements.
• Experience supporting audits, regulatory inspections, change control, and risk management.
• Experience leading cross-functional projects with measurable improvements in quality, yield, capacity, or cost.
• Experience with new product transfers, equipment implementation, automation, and advanced manufacturing technologies.
• Experience working with complex manufacturing equipment and automated production systems.