The Manufacturing Engineer is responsible for leading NPI manufacturing engineering activities, including process development, equipment readiness, routing, documentation, validation, and continuous improvement to meet volume, quality, safety (OHS), cost, yield, and line efficiency targets.
This role ensures product manufacturability by partnering with Product Development, Quality, Production, and Supply Chain teams to translate new product designs into stable, compliant, and production-ready manufacturing processes before handover.
Let’s talk about Responsibilities
Develop, implement, and optimize manufacturing processes, equipment, tooling, routing, work instructions, and documentation to meet NPI and production targets
Collaborate with Product Development teams to provide DFM/DFA input and ensure product designs are robust, manufacturable, serviceable, and scalable for production
Lead and support New Product Introduction (NPI) activities, including prototype builds, process trials, testing, risk assessment, verification, validation, and production handover
Troubleshoot and resolve manufacturing, process, equipment, and technical issues to improve yield, reduce downtime, and support stable production ramp-up
Establish and maintain production procedures, work instructions, SOPs, process flows, routings, cycle time standards, and controlled manufacturing documentation
Provide training and technical coaching to production teams on new equipment, processes, procedures, quality requirements, and safe ways of working
Drive continuous improvement initiatives using Lean, Six Sigma, GMP, data analysis, and structured problem-solving to improve cost, yield, quality, and efficiency
Ensure compliance with Quality, GMP, regulatory, and Occupational Health & Safety (OHS) standards throughout NPI development, validation, and production transfer
Initiate, execute, and document process validation activities, including protocol preparation, trial execution, data review, report completion, and evidence retention
Build strong cross-functional relationships with Production, Quality, Product Development, Supply Chain, and Engineering teams to remove risks and close NPI actions
Participate in or lead projects to improve manufacturing performance, COGS, yield, line efficiency, routing accuracy, cycle time, and technology readiness milestones
Use data-driven methods to identify trends, verify assumptions, evaluate options, and recommend effective technical actions.
Develop and maintain CAD models and engineering drawings to support process development, tooling, fixtures, validation, and manufacturing handover.
Let’s talk about Qualifications and Experience
Preferred:
Bachelor's Degree in Engineering (Mechanical, Manufacturing, Industrial, Mechatronics, or related field)
Minimum 3 years of relevant experience in manufacturing engineering, NPI engineering, process engineering, or a similar technical environment
Strong understanding of manufacturing processes, process validation, production systems, routings, cycle time studies, tooling, fixtures, and equipment readiness
Proven experience in troubleshooting and resolving technical, process, equipment, and manufacturability issues using structured problem-solving methods
Familiarity with GMP, quality systems, regulatory expectations, OHS requirements, and documentation control in a manufacturing environment
Ability to apply company policies, engineering standards, risk-based thinking, and data-driven decision making to solve a variety of technical challenges
Experience in medical device, healthcare, or other regulated manufacturing environments
Certification or hands-on experience with Lean Manufacturing, Six Sigma, process capability, validation, or operational excellence methodologies
Strong exposure to New Product Introduction (NPI), design transfer, prototype builds, process scale-up, and product lifecycle support.
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