The Manufacturing Engineer will be responsible for supporting the sustaining manufacturing line to a high scale production. You will support processes as required to provide daily operations support to the manufacturing floor including inputs to monitoring and control to maintain robust processes. This role will interact with different areas in the organization including quality, R&D, Regulatory, Operations, Marketing, Supply Management etc.  

Provide support to the manufacturing processes ensuring output. Support day-to-day activities as manufacturing needs to ensure optimization of manufacturing and/or investigations as needed.  

Responsibilities: 

• Oversee shift operations to maintain continuous production, resolving documentation, material, and equipment issues promptly.  

• Act as liaison between production and engineering management, providing updates and escalating issues as needed.  

• Author and maintain production documents, templates, reports, specifications, and equipment protocols; conduct equipment qualifications and validations.  

• Investigate and resolve equipment, process, and product non-conformances through root cause analysis and corrective actions.  

• Develop innovative solutions to recurring production challenges and collaborate with production personnel on improvement initiatives.  

• Provide training and support to production teams to enhance process understanding and efficiency.  

• Partner with New Product Introduction/Transfer teams to execute calibration, process validation (IQ/OQ/PQ), and Test Method Validation (TMV) protocols.  

• Design and optimize manufacturing processes, layouts, and workflows for assemblies, equipment installation, and material handling.  

• Ensure compliance with regulatory requirements and incorporate inspection and test requirements into production plans.  

• Monitor and improve machinery performance, initiating corrective actions to maintain product quality.  

• Apply statistical process control techniques and provide guidance on design concepts to maximize equipment utilization and manufacturing efficiency. 

Basic Qualifications: 

• Bachelor’s degree in engineering or sciences with 2+ years of experience  

• Strong written and verbal proficiency in English and Malay. 

• Ability and willingness to travel internationally for extended periods, typically ranging from 2 to 6 months or longer, depending on on-the-job training needs.   

Desired Skills & Experience: 

• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification. 

• Knowledge of GD&T & experience in interpreting mechanical drawings. 

• Strong communication skills, both verbal and written. 

• Experience with risk management, including but not limited to Process Failure Mode Effects Analysis (pFMEA), Design Failure Mode Effects Analysis (dFMEA), fault tree analysis, or other risk management tools. 

• Experience in FDA 21 CFR Part 820 Medical Device Manufacturing, or ISO 13485 is preferred. 

• Knowledge of Engineering Change management processes and PLM tools such as Agile, PTC Windchill is preferred. (Any PLM)