We are seeking a Process Engineer to support a growing regulated manufacturing operation in Draper, Utah. This engineer will be responsible for sustaining and improving manufacturing processes, maintaining established production standards, reducing scrap and process variation, and supporting continuous improvement initiatives.
The ideal candidate is a methodical, data-driven problem solver who can understand manufacturing processes, analyze process performance, and develop practical solutions in a regulated production environment. This position will work closely with manufacturing technicians, engineers, quality, and other cross-functional teams.
Key Responsibilities
- Support and sustain manufacturing processes to meet established yield, output, quality, and efficiency standards.
- Investigate manufacturing issues and identify root causes using structured, data-driven problem-solving methodologies.
- Apply Lean Six Sigma principles, DMAIC, and other continuous improvement methodologies to manufacturing challenges.
- Perform process characterization and analyze process data to identify sources of variation and opportunities for improvement.
- Use statistical analysis and tools such as Minitab to evaluate manufacturing processes and support engineering decisions.
- Lead or support small-scale continuous improvement projects focused on yield improvement, scrap reduction, process efficiency, and labor requirements.
- Support process, equipment, and component changes within a regulated quality system.
- Develop and/or execute validation activities, including IQ, OQ, and PQ as appropriate based on change impact.
- Support change control and implementation of manufacturing changes while ensuring appropriate quality system documentation is completed.
- Work approximately 20% of the time on the manufacturing floor, partnering with technicians and manufacturing personnel to understand and resolve process issues.
- Communicate effectively with cross-functional teams and provide clear technical recommendations based on data and analysis.
- Maintain a methodical approach to troubleshooting, documentation, validation, and project execution.
Qualifications
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related engineering discipline.
- 3-10 years of process or manufacturing engineering experience.
- Experience in a regulated manufacturing environment, preferably medical device or pharmaceutical.
- Demonstrated experience applying continuous improvement or Lean Six Sigma methodologies.
- Strong understanding of structured problem solving and root cause analysis.
- Experience with process characterization, statistical analysis, and manufacturing data.
- Experience with Minitab or comparable statistical analysis software.
- Experience supporting process validation, equipment qualification, change control, or related regulated manufacturing activities.
- Strong communication and interpersonal skills with the ability to work effectively with manufacturing and technical teams.
- Ability to work onsite five days per week in Draper, UT.
Preferred Qualifications
- Experience with metal manufacturing processes such as heat treatment, electropolishing, laser cutting, or similar precision manufacturing processes.
- Experience with plastics processing, including polymerization, extrusion, or injection molding.
- Lean Six Sigma certification or formal training.
- Experience with DOE, SPC, process capability analysis, or other statistical process improvement tools.
- Experience working in medical device manufacturing.