Manufacturing Engineer II

Title: Manufacturing Engineer II

Location: Draper, UT

Pay: $36.00-$42.00/hr

Schedule: Standard Office Hrs

Duration: 12-Month Contract




The Manufacturing Engineer will support medical device component production by driving validation, troubleshooting, and continuous improvement activities across manufacturing operations. This role applies engineering principles to improve process capability, quality, yield, efficiency, equipment performance, and overall manufacturability.




The ideal candidate will have experience in a regulated manufacturing environment and a strong understanding of metals manufacturing processes, including laser cutting, heat treatment, shape setting, electropolishing, passivation, welding/joining, machining, cleaning, and inspection.

Responsibilities

• Provide technical support for metals manufacturing processes, equipment, tooling, fixtures, inspection methods, and production documentation.
• Support manufacturing engineering projects, including equipment and 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 manufacturing and compliance issues, including CAPAs, nonconformances, audit observations, process excursions, and yield issues.
• Develop and revise work instructions, process documentation, training materials, validation documentation, and technical reports.
• Lead project planning and execution to ensure technical deliverables are completed on schedule and meet stakeholder expectations.
• Support compliance with EHS, quality system, and cleanroom medical device manufacturing requirements.
• Conduct time, motion, and methods studies to establish standard production rates and improve operational efficiency.

Required Qualifications

• Bachelor's degree in Engineering or a related field.
• 2+ years of manufacturing engineering experience.
• Experience supporting regulated manufacturing environments, preferably within the medical device industry.
• Knowledge of metals manufacturing processes, equipment, tooling, fixtures, and inspection methods.
• Experience with process validation, equipment qualification, and continuous improvement initiatives.
• Strong analytical, problem-solving, organizational, and critical thinking skills.
• Ability to lead engineering studies, validations, investigations, and process improvement projects.
• Strong written and verbal communication skills with the ability to present technical information to cross-functional teams.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office.

Preferred Qualifications

• Experience with Lean Manufacturing and Six Sigma methodologies.
• Knowledge of risk analysis tools and project management practices.
• Experience working in cleanroom manufacturing environments.
• Familiarity with quality systems, CAPAs, nonconformance investigations, and regulatory compliance.

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