Process Engineer

Novozen Healthcare LLC

Utah

On-site

USD 85,000 - 110,000

Full time

5 hours ago
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Job summary

Novozen Healthcare LLC seeks a skilled Process/Manufacturing Engineer to support and sustain manufacturing processes, using data-driven methods to improve yield, quality, and efficiency. You will investigate issues, apply Lean Six Sigma and DMAIC, and lead projects to reduce scrap and optimize labour.

This role requires a regulated manufacturing background and hands-on floor exposure. The ideal candidate holds a related engineering degree, 3+ years of experience, and strong problem-solving

Qualifications

  • Experience in a regulated manufacturing environment is required.
  • Lean Six Sigma principles and continuous improvement experience are essential.
  • Strong analytical and problem-solving capabilities are required.
  • Experience with process validation, equipment qualification, and change control is preferred.
  • Excellent communication and collaboration across functions is expected.

Responsibilities

  • Support manufacturing processes to meet yield, output, quality, and efficiency targets.
  • Investigate manufacturing issues and identify root causes using data-driven methods.
  • Apply Lean Six Sigma, DMAIC, and continuous improvement methodologies.
  • Characterise processes and analyse data to identify variation and improvement opportunities.
  • Lead or support improvement projects focused on yield, scrap reduction, and efficiency.
  • Support changes within a regulated quality system and perform validation activities.
  • Spend about 20% of time on the floor with technicians and production teams.
  • Collaborate with engineering, manufacturing, quality, and cross-functional teams to implement solutions.
  • Maintain systematic troubleshooting, documentation, validation, and project execution.

Skills

Root cause analysis
Lean principles
Analytical thinking
Troubleshooting
Communication
Interpersonal skills
Cross-functional collaboration
Problem solving

Education

Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline

Tools

Minitab
Statistical software

Job description

Support and sustain manufacturing processes to meet yield, output, quality, and efficiency targets

Investigate manufacturing issues and identify root causes using structured, data-driven problem-solving methods

Apply Lean Six Sigma, DMAIC, and continuous improvement methodologies to manufacturing challenges

Perform process characterisation and analyse manufacturing data to identify process variation and improvement opportunities

Use Minitab or comparable statistical tools to evaluate process performance and support engineering decisions

Lead or support improvement projects focused on yield enhancement, scrap reduction, process efficiency, and labour optimisation

Support process, equipment, and component changes within a regulated quality system

Develop and execute process validation activities, including IQ, OQ, and PQ, as applicable

Support change control activities and ensure accurate quality system documentation

Spend approximately 20% of the time on the manufacturing floor working with technicians and production teams to troubleshoot issues

Collaborate with engineering, manufacturing, quality, and other cross-functional teams to implement practical solutions

Maintain a systematic approach to troubleshooting, documentation, validation, and project execution

Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline

3+ years of process engineering or manufacturing engineering experience

Experience in a regulated manufacturing environment, preferably medical device or pharmaceutical manufacturing

Demonstrated experience with continuous improvement methodologies and Lean Six Sigma principles

Strong understanding of root cause analysis and structured problem-solving techniques

Experience with process characterisation, statistical analysis, and manufacturing data evaluation

Proficiency in Minitab or comparable statistical analysis software

Experience supporting process validation, equipment qualification, change control, or related regulated manufacturing activities

Strong analytical, troubleshooting, communication, and interpersonal skills

Experience with precision metal manufacturing processes such as heat treatment, electropolishing, or laser cutting

Experience with plastics processing, including polymerisation, extrusion, or injection molding

Lean Six Sigma certification or formal training

Knowledge of DOE, SPC, process capability analysis, and other statistical process improvement tools

Previous experience in medical device manufacturing

This contract position does not include employer-provided benefits.

We are committed to providing equal employment opportunities to all qualified individuals. We make employment decisions based on job-related qualifications, business needs, and other lawful considerations, without regard to any characteristic protected by applicable federal, state, or local law.

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