Job Description

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.

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.

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.