Process Engineer II

Job Title: Process Engineer II

Join a transformative MedTech player, poised to expand in Malaysia and shape the region's healthcare ecosystem.

Job Description

Responsibilities may include the following and other duties as assigned:

• Provides technical and sustaining engineering support in a manufacturing area
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, and production yields for existing products
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules
• Interacts with product design and development personnel to ensure that processes and designs are compatible
• May develop and conduct statistical analysis or recommend additions to document work
• Leads the innovation, development, and/or optimization of new manufacturing concepts, processes, and procedures for transfer to manufacturing operations
• Includes scouting and feasibility work, material selection, process and equipment selection, tooling/fixture and equipment installation, and assessment of inputs, outputs, and alignment to requirements
• Develops manufacturing processes applicable to statistical process control and may develop those techniques including measurement systems
• Ensures processes and procedures are in compliance with regulations
• Revises proposals for new product specifications or modifications to current specifications established by design documentation
• Initiates, evaluates, approves, and implements Engineering Change Orders (ECR/ECO)
• Analyzes and determines the conformance of materials and assemblies
• Provides training to production personnel, technicians, and engineers
• Leads or participates in development, training, qualification, and validation activities for product or technology transfers

Technical Specialist Career Stream

An individual contributor with responsibility in technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and/or manages assigned projects and works with other stakeholders to achieve desired results. May mentor colleagues or direct the work of lower-level professionals. Majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapiesfrom design to implementationwhile adhering to policies and applying specialized knowledge and skills.

Differentiating Factors

Autonomy

• Established and productive individual contributor
• Works independently with general supervision on larger, moderately complex projects or assignments

Organizational Impact

• Sets objectives for own job area to meet project and assignment goals
• Contributes to completion of project milestones
• May be involved in cross-functional assignments

Innovation and Complexity

• Faces general problems that may require understanding of broader issues or job areas
• Makes adjustments or recommends enhancements to systems and processes to improve effectiveness

Communication and Influence

• Communicates primarily with internal contacts
• External interactions are less complex and typically problem-solving in nature
• Shares information, status, needs, and issues to inform and support decision-making

Leadership and Talent Management

• May provide guidance and assistance to entry-level professionals or employees in support roles

Required Knowledge and Experience

• Bachelor's degree in Electrical/Electronic Engineering, Industrial Engineering, Mechanical Engineering, Material Science, Chemical Engineering, or related technical discipline
• 3 to 5 years of experience in a manufacturing environment, preferably in medical devices or other regulated industries
• Hands-on experience using Minitab for data analysis and Statistical Process Control (SPC) implementation
• Experience in Lean Six Sigma methodology and continuous improvement programs
• Strong written and verbal proficiency in English and Malay
• Willingness and ability to travel internationally for extended periods (typically 2 to 6 months or longer depending on training needs)
• Practical knowledge and demonstrated competence typically obtained through advanced education and experience