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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
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.