Lead Metals Manufacturing Engineer for Medical Devices

Infosoft Inc.; Draper (UT); On-site; USD 90,000 - 98,000; Full time

Job summary

Infosoft Inc. seeks a Principal Manufacturing Engineer to provide technical leadership for metals manufacturing processes in medical device components in Draper, Utah.

This onsite role focuses on validation, troubleshooting, and continuous improvement across manufacturing operations to enhance process capability, quality, yield, and equipment performance. The ideal candidate will have strong experience in regulated manufacturing and metals processing, including laser cutting, heat treatment,

Qualifications

• Strong experience in regulated manufacturing.
• Metals manufacturing processes including laser cutting.
• Heat treatment and electropolishing.
• Welding/joining, machining, inspection.

Responsibilities

• Provide technical support for metals manufacturing processes, equipment, tooling, fixtures, inspection methods, and production documentation.
• Lead complex manufacturing engineering projects, including equipment/process qualification, validation, and production support.
• Design, execute, and document engineering studies, experiments, protocols, and technical reports to qualify or improve manufacturing processes.
• Identify and implement process improvements using Lean, Six Sigma, root cause analysis, statistical analysis, and risk-based engineering methods.
• Analyze and resolve complex manufacturing and compliance issues, including CAPAs, nonconformances, audit observations, process excursions, and yield issues.
• Develop and revise work instructions, process documentation, training materials, validation documents, and technical reports.
• Lead project planning and execution to ensure technical deliverables are completed on schedule and meet stakeholder expectations.
• Support compliance with applicable EHS, quality system, and cleanroom medical device manufacturing requirements.
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.

Skills

Manufacturing engineering

Process optimization

Lean Six Sigma

Validation

Investigation

Documentation

Leadership

Problem-solving

Communications

Tools

Microsoft Office

Job description

Infosoft Inc. seeks a Principal Manufacturing Engineer to provide technical leadership for metals manufacturing processes in medical device components in Draper, Utah.

This onsite role focuses on validation, troubleshooting, and continuous improvement across manufacturing operations to enhance process capability, quality, yield, and equipment performance. The ideal candidate will have strong experience in regulated manufacturing and metals processing, including laser cutting, heat treatment,