NPI Manufacturing Engineer

ResMed (Malaysia) Sdn Bhd; Johor Bahru; On-site; MYR 90,000 - 130,000; Full time

Job summary

ResMed (Malaysia) Sdn Bhd in Johor Bahru is seeking a Manufacturing Engineer to lead NPI manufacturing activities, develop processes, validate equipment, and drive continuous improvement to meet cost, yield, and safety targets.

You will collaborate with Product Development, Quality, Production and Supply Chain to translate designs into production-ready processes, perform trials, troubleshooting, and handover.

Qualifications

• 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.

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.

Skills

Manufacturing Engineering

NPI Engineering

Process Engineering

Lean Six Sigma

GMP

Data Analysis

Problem Solving

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor's Degree in Engineering

Tools

CAD

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.

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Pharmaceuticals, Biotechnology & Medical Devices 51-100 employees

ResMed is a global leader in the design, manufacture and distribution of innovative products for the diagnosis, treatment and management of sleep disordered breathing and respiratory disorders. The company has experienced sustained and significant growth since inception and now employs approximately 2500 people world-wide. The global business environment is becoming increasingly competitive, which is resulting in a greater emphasis on innovation and a cost effective approach to achieving market leadership through technological advances.

What can I earn as a Manufacturing Engineer