Principal Manufacturing Engineer- 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

Job Title: Principal Manufacturing Engineer- Medical Devices

Pay Rate: $65 to $70.78/HR

Duration: 18 months

Location: Draper, UT (Onsite)

Our Client is a Global medical device Manufacturer.

We are looking for a Principal Manufacturing Engineer who will provide technical leadership for metals manufacturing processes supporting medical device component production. This role will lead validation, troubleshooting, and continuous improvement activities across manufacturing operations. The engineer will apply advanced engineering principles to improve process capability, quality, yield, efficiency, equipment performance, and manufacturability.

The ideal candidate has strong experience in regulated manufacturing and demonstrated knowledge of metals manufacturing processes such as laser cutting, heat treatment, shape setting, electropolishing, passivation, welding/joining, machining, cleaning, and inspection.

• 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:

• Creativity, verbal and written communication skills, analytical and problem-solving ability.
• Strong technical expertise in manufacturing engineering and process optimization.
• Experience with metals manufacturing processes, equipment, tooling, fixtures, and inspection methods.
• Advanced problem-solving, analytical, organizational, and critical-thinking skills.
• Ability to lead complex engineering studies, validations, investigations, and improvement projects.
• Ability to translate complex technical information for production teams, technical partners, and leadership.
• Ability to manage competing priorities in a fast-paced manufacturing environment.
• Strict attention to detail and strong commitment to quality, safety, and compliance.
• Proficiency with Microsoft Office
• Experience with Lean, Six Sigma, process validation, risk analysis, and project management tools preferred.