NPI Manufacturing Engineer

Medifox DAN GmbH; Johor Bahru; On-site; MYR 60,000 - 90,000; Full time

Job summary

Medifox DAN GmbH in Malaysia is seeking a Manufacturing Engineer to lead NPI manufacturing activities, including process development, equipment readiness, routing, documentation, validation, and continuous improvement to meet targets for volume, quality, safety (OHS), cost, yield, and line efficiency.

You will partner with Product Development, Quality, Production and Supply Chain to translate new product designs into stable, compliant, and production-ready processes before handover, while

Qualifications

• Bachelor's degree in Engineering (Mechanical, Manufacturing, Industrial, Mechatronics, or related).
• Minimum 3 years of experience in manufacturing engineering, NPI engineering, process engineering, or related field.
• Strong understanding of manufacturing processes, process validation, production systems, routings, tooling, and equipment readiness.
• Experience troubleshooting technical issues using structured problem-solving methods.
• Familiarity with GMP, quality systems, regulatory expectations, OHS requirements, and documentation control.
• Experience in medical device, healthcare, or other regulated manufacturing environments.

Responsibilities

• Develop, implement, and optimize manufacturing processes, equipment, tooling, routing, work instructions, and documentation to meet NPI and production targets.
• Collaborate with Product Development to provide DFM/DFA input and ensure designs are robust and manufacturable.
• Lead NPI activities including prototype builds, process trials, testing, verification, validation, and production handover.
• Troubleshoot and resolve manufacturing and process issues to improve yield and reduce downtime.
• Establish and maintain production procedures, SOPs, process flows, routings, and controlled documentation.
• Provide training and coaching to production teams on new equipment, processes, quality requirements, and safe work practices.
• Drive continuous improvement using Lean, Six Sigma, GMP, and data-driven problem solving to improve cost and efficiency.
• Ensure compliance with GMP and OHS standards throughout development, validation, and transfer to production.
• Initiate and document process validation activities, including protocol, data review, and evidence retention.
• Foster cross-functional relationships to remove risks and close NPI actions.
• Participate in projects to improve manufacturing performance and line efficiency.
• Use data to identify trends, evaluate options, and recommend technical actions.
• Develop CAD models and drawings to support process development and tooling.

Skills

NPI engineering

Lean Manufacturing

Six Sigma

GMP knowledge

Data-driven decisions

Process troubleshooting

Education

Bachelor's Degree in Engineering (Mechanical, Manufacturing, Industrial, Mechatronics, or related)

Tools

CAD software

Engineering drawings

Job description

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.

Joining us is more than saying yes to making the world a healthier place. It's discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. We commit to respond to every applicant.