Process Engineer

Key Responsibilities

Process Improvement & Manufacturing Excellence

• Lead continuous improvement initiatives focused on safety, quality, throughput, cost reduction, material utilization, and Overall Equipment Effectiveness (OEE).
• Analyze manufacturing processes and identify opportunities to improve efficiency, reduce variability, and increase productivity.
• Investigate process issues and implement sustainable corrective and preventive actions.
• Utilize data analysis and statistical methods to evaluate process performance and drive decision-making.
• Support new product introductions, process transfers, and manufacturing scale-up activities.
• Develop and maintain process documentation, specifications, work instructions, and standard operating procedures (SOPs).

Latex Manufacturing Expertise

• Provide technical leadership and support for liquid latex casting, dipping, curing, and associated manufacturing processes.
• Troubleshoot complex manufacturing challenges and identify root causes of process variability.
• Partner with Operations and Quality teams to ensure consistent product performance and process reliability.
• Recommend and implement process enhancements that improve product quality and manufacturing efficiency.

Process Validation & Regulatory Compliance

• Lead process validation activities in compliance with applicable medical device regulations and quality management system requirements.
• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support equipment qualifications, process changes, revalidations, and continuous process verification activities.
• Analyze validation data using statistical techniques and ensure manufacturing processes remain capable and controlled.
• Collaborate with Quality and Regulatory teams to maintain validated manufacturing processes and support regulatory compliance.
• Establish validation standards, best practices, and documentation systems across the facility.
• Support internal and external audits by providing technical expertise and validation documentation.
• Ensure engineering activities comply with applicable quality system requirements and industry standards.

Capital Projects

• Identify opportunities for equipment, automation, facility, and process improvements.
• Develop technical justifications, cost-benefit analyses, and capital expenditure requests.
• Lead capital projects from concept, design, and vendor selection through installation, qualification, and commissioning.
• Manage project timelines, budgets, and resources to ensure successful project execution.
• Coordinate with global engineering resources and external suppliers as necessary.

Training & Technical Leadership

• Serve as a technical resource and subject matter expert for manufacturing processes and validation activities.
• Train, mentor, and coach engineers, technicians, production personnel, and quality staff on process engineering principles and validation methodologies.
• Build local organizational capability in process control, continuous improvement, root cause analysis, and validation execution.
• Foster a culture of technical excellence, accountability, and continuous improvement throughout the facility.

Global Collaboration

• Serve as the primary engineering liaison between the Malaysia manufacturing facility and global engineering leadership.
• Provide regular updates on manufacturing performance, project status, technical risks, and resource needs.
• Effectively communicate site challenges, opportunities, and capital requirements to leadership teams located outside Malaysia.
• Collaborate across multiple functions and geographic regions to support business objectives.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum of 7 years of manufacturing process engineering experience, preferably in a regulated manufacturing environment.
• Demonstrated experience with liquid latex casting, dipping, elastomer manufacturing, or similar production processes.
• Proven experience leading and executing process validation activities, including IQ, OQ, and PQ protocols.
• Experience leading capital projects from concept through implementation and commissioning.
• Strong understanding of statistical analysis, process capability studies, root cause analysis, and process control methodologies.
• Working knowledge of medical device quality systems and validation requirements.
• Excellent written and verbal communication skills in English.
• Strong project management, organizational, and problem-solving skills.
• Ability to work independently with minimal supervision while effectively supporting a global organization.

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Preferred Qualifications

• Experience within medical device manufacturing.
• Knowledge of ISO 13485, FDA Quality System Regulations, and other applicable medical device regulatory requirements.
• Six Sigma Green Belt, Black Belt, or equivalent continuous improvement certification.
• Experience with automation, controls, or advanced manufacturing technologies.
• Proficiency in statistical analysis software such as Minitab.
• Experience supporting regulatory inspections and customer audits.
• Experience working within multinational manufacturing organizations.

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Success Measures

Within the first 12-18 months, the successful candidate will:

• Establish themself as the site's primary engineering and validation resource.
• Identify and execute high-impact process improvement opportunities.
• Improve manufacturing efficiency, product quality, and process stability.
• Develop and implement a sustainable pipeline of capital improvement projects.
• Strengthen process validation practices and maintain validated manufacturing processes.
• Improve technical capability within the facility through training and mentorship.
• Build strong collaboration and communication with global engineering leadership and cross-functional partners.

Travel: Occasional travel may be required to support global engineering initiatives, training activities, supplier visits, or other company locations.