Principal Engineer

Hydrogen Group; Draper (UT); On-site; USD 80,000 - 87,000; Full time

Job summary

Hydrogen Group seeks an experienced Principal Manufacturing Engineer to lead metals manufacturing processes for medical device production. The role focuses on process validation, equipment qualification, and continuous improvement in a highly regulated environment.

You will drive Lean Six Sigma initiatives, troubleshoot complex issues, and mentor cross-functional teams to achieve quality, yield, and regulatory compliance. 18-month contract in Draper, UT.

Qualifications

• Bachelor's degree in Engineering is required.
• 8+ years of Manufacturing Engineering experience required.
• Experience in medical device industry or other highly regulated manufacturing environment.
• Lean Six Sigma Green Belt or Black Belt is required.

Responsibilities

• Lead manufacturing engineering projects involving process validation, equipment qualification, and production support.
• Design, execute, and document engineering studies, experiments, protocols, and technical reports.
• Develop and improve metals manufacturing processes including laser cutting, heat treatment, shape setting, electropolishing, passivation, welding and joining, machining, cleaning, and inspection.
• Investigate and resolve manufacturing issues including CAPAs, nonconformances, process deviations, audit findings, and yield concerns.
• Implement Lean Manufacturing and Six Sigma methodologies to improve process capability and operational efficiency.
• Perform statistical analysis using Minitab to support process improvements and validation activities.
• Develop and revise work instructions, validation documents, training materials, and technical reports.
• Conduct time studies and analyze production methods to improve manufacturing efficiency.
• Ensure compliance with quality systems, environmental health & safety (EHS), and medical device manufacturing regulations.

Skills

Manufacturing engineering

Metals manufacturing

Process validation

Equipment qualification

Minitab

Lean Six Sigma

CAPA investigations

Root cause analysis

Project management

Cross-functional leadership

Education

Bachelor's degree in Engineering

8+ years manufacturing engineering experience

Tools

Minitab

Job description

We are seeking an experienced Principal Manufacturing Engineer to provide technical leadership for metals manufacturing processes supporting medical device production. This role will lead process validation, troubleshooting, continuous improvement initiatives, and complex manufacturing engineering projects while driving quality, efficiency, and compliance in a highly regulated environment.

• Lead technical initiatives for metals manufacturing processes, equipment, tooling, fixtures, and inspection methods.
• Support process validation, equipment qualification, and manufacturing readiness.
• Drive continuous improvement using Lean, Six Sigma, statistical analysis, and risk-based engineering principles.
• Troubleshoot complex manufacturing issues, improve yield, and optimize production processes.
• Collaborate with cross-functional teams to support manufacturing excellence and regulatory compliance.
• Lead engineering projects from planning through execution while mentoring and influencing technical teams.

Principal Manufacturing Engineer

LOCATION: Draper, UT

SCHEDULE: Standard Business Hours

DURATION: 18-Month Contract

PAY: $58-63/hour

Job Responsibilities:

We are seeking an experienced Principal Manufacturing Engineer to provide technical leadership for metals manufacturing processes supporting medical device production. This role will lead process validation, troubleshooting, continuous improvement initiatives, and complex manufacturing engineering projects while driving quality, efficiency, and compliance in a highly regulated environment.

• Lead technical initiatives for metals manufacturing processes, equipment, tooling, fixtures, and inspection methods.
• Support process validation, equipment qualification, and manufacturing readiness.
• Drive continuous improvement using Lean, Six Sigma, statistical analysis, and risk-based engineering principles.
• Troubleshoot complex manufacturing issues, improve yield, and optimize production processes.
• Collaborate with cross-functional teams to support manufacturing excellence and regulatory compliance.
• Lead engineering projects from planning through execution while mentoring and influencing technical teams.

Essential Duties & Job Functions:

• Lead manufacturing engineering projects involving process validation, equipment qualification, and production support.
• Design, execute, and document engineering studies, experiments, protocols, and technical reports.
• Develop and improve metals manufacturing processes including:
  • Laser cutting
  • Heat treatment
  • Shape setting
  • Electropolishing
  • Passivation
  • Welding and joining
  • Machining
  • Cleaning
  • Inspection
• Investigate and resolve manufacturing issues including CAPAs, nonconformances, process deviations, audit findings, and yield concerns.
• Implement Lean Manufacturing and Six Sigma methodologies to improve process capability and operational efficiency.
• Perform statistical analysis using Minitab to support process improvements and validation activities.
• Develop and revise work instructions, validation documents, training materials, and technical reports.
• Conduct time studies and analyze production methods to improve manufacturing efficiency.
• Ensure compliance with quality systems, environmental health & safety (EHS), and medical device manufacturing regulations.

Knowledge & Skills:

• Extensive experience in manufacturing engineering within a regulated industry.
• Strong expertise in metals manufacturing processes.
• Experience with process validation, equipment qualification, and risk analysis.
• Proficiency with Minitab for statistical analysis.
• Lean Six Sigma Green Belt or Black Belt certification (required).
• Strong knowledge of:
  • Manufacturing equipment
  • Tooling and fixtures
  • Inspection methods
  • Process optimization
  • Root cause analysis
  • CAPA investigations
• Excellent analytical, project management, and technical leadership skills.
• Ability to lead cross-functional engineering teams and influence stakeholders.
• Strong communication and documentation skills.
• High attention to detail and commitment to quality and compliance.

Education & Experience:

• Bachelor's degree in Engineering (required).
• 8+ years of Manufacturing Engineering experience (required).
• Experience in the medical device industry or another highly regulated manufacturing environment.
• Lean Six Sigma Green Belt or Black Belt (required).
• Experience with metals manufacturing processes, validation, and continuous improvement.

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