The NPI (New Product Introduction) Manufacturing Engineer plays a key role in supporting the successful industrialization and launch of new headgear products within ResMed Malaysia’s manufacturing operations. The role ensures new designs are manufacturable, processes are robust, equipment and documentation are ready, and products are introduced on time, within budget, and in compliance with quality, regulatory, and EHS requirements.
Key Responsibilities
1. NPI Project Support
Collaborate with global R&D, program managers, and manufacturing teams to transition new headgear designs from concept to mass production.
Participate in design reviews to provide manufacturability and process feasibility analysis feedback (DFM/DFA).
Support Gate reviews and ensure deliverables are completed per NPI roadmap.
2. Process & Equipment Development
Develop, qualify, and validate new manufacturing processes for sewing, lamination, bonding/gluing, cutting, and assembly of headgear.
Work with Equipment & Technology Development team to specify, source, and validate new production equipment/tooling.
Conduct process capability studies (Cp, Cpk) and ensure process robustness.
3. Validation & Documentation
Prepare and execute process validation protocols (IQ/OQ/PQ) in compliance with medical device regulations.
Generate and release manufacturing documentation including Work Instructions (WI), Control Plans, and PFMEA.
Support ECO implementation and BOM/routing setup in ERP system.
4. Quality & Compliance
Ensure processes and documentation comply with ISO 13485, FDA, MDSAP and internal QMS requirements.
Collaborate with Quality Engineering on CTQ (Critical to Quality) identification, risk analysis, and control strategy.
Support supplier qualification and PPAP for critical materials (fabrics, foams, elastics).
5. Pilot Builds & Launch
Support engineering builds, V&V, ECS, and pilot runs, ensuring build readiness, data collection, and issue resolution.
Drive yield improvement, FPY (First Pass Yield), and cycle time achievement before ramp-up.
Support training of operators and technicians during new line setup.
6. Continuous Improvement & Handover
Identify opportunities for cost reduction (VAVE), process simplification, and automation.
Ensure smooth handover of stabilized processes to Sustaining Engineering/Operations.
Document lessons learned for future product launches.
Key Requirements
Education & Experience
Bachelor’s Degree in Mechanical, Manufacturing, Industrial, Bio medical or related Engineering discipline.
2–5 years of experience in New Product Introduction, process development, or manufacturing engineering (preferably in medical device, textile, or consumer product industries).
Technical Skills
Knowledge of sewing, lamination, bonding/gluing, and textile-based assembly processes.
Experience in process validation (IQ/OQ/PQ), statistical analysis, and capability studies.
Familiar with PFMEA, control plan, SPC, DOE, and Lean Six Sigma tools.
Proficiency in CAD (SolidWorks, AutoCAD) and MS Office/Project is an advantage.
ERP/MRP systems knowledge (SAP, Oracle, or equivalent) is desirable.
Soft Skills
Strong problem-solving, project management and analytical skills.
Effective communication and cross-functional teamwork in a global environment.
Ability to work under tight timelines with a high level of accountability.
Key Performance Indicators (KPIs)
On-time completion of NPI deliverables at each gate.
Process capability and FPY achievement before ramp-up.
Compliance to validation and QMS requirements (no audit findings).
Successful handover of stable processes to Sustaining team.
Contribution to cost, quality, and efficiency improvements.
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. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.