Engineer, NPI Manufacturing

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.

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 Qualifications & Experience Required: Bachelor's Degree in Engineering (Mechanical, Manufacturing, Industrial, Mechatronics, or related field) Minimum 5 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 Preferred: 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 Strong project management, stakeholder management, or technical project leadership experience in cross-functional environments Key Competencies Strong analytical, structured problem-solving, and data-driven decision-making skills Effective communication, stakeholder management, and cross-functional influencing skills Ability to work independently while collaborating effectively