NPI Manufacturing Engineer: Launch & Process Excellence

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

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