Process Engineering Manager

Bard Sdn Bhd; Kulim; On-site; MYR 180,000 - 320,000; Full time

Job summary

BD seeks a Senior Process Engineering Manager to lead the Process Engineering function at our Kulim facility in Malaysia. You will drive manufacturing excellence, lead cross-functional teams including Operations, Quality, and Regulatory Affairs, and shape strategies for yield, cost, and quality.

You will oversee material qualification, process technology development, and continuous improvement programs to sustain robust and compliant manufacturing operations.

Qualifications

• Minimum 5 years of experience in process/material/manufacturing engineering within a manufacturing environment.
• Experience leading engineering projects, material qualification activities, and validation programs.
• Proven ability to drive yield improvement, cost reduction, and operational excellence.
• Strong leadership, communication, and stakeholder management skills.
• Knowledge of statistical methods and data analysis.

Responsibilities

• Lead and manage Process Engineering activities to support manufacturing performance, quality improvement, cost reduction, and operational excellence objectives.
• Develop and execute process improvement strategies to enhance yield, productivity, efficiency and product quality.
• Establish priorities, resource plans, project schedules and deliverables for engineering initiatives.
• Drive accountability for process performance, milestones and continuous improvement goals.
• Lead materials and process technology development to support product quality and cost optimization.
• Oversee material qualification activities and validation programs (IQ/OQ/PQ).
• Provide technical leadership on process optimization, troubleshooting, and quality initiatives.
• Manage engineering projects from concept to implementation and ensure compliance with quality/regulatory requirements.
• Build cross-functional partnerships and develop a high-performing Process Engineering team.

Skills

Leadership

Process optimization

Continuous improvement

Project management

Root cause analysis

Data analysis

Education

Bachelor's degree in Engineering

Lean Six Sigma certification (advantage)

Job description

At BD, we are committed to advancing the world of health™. As a Process Engineering Manager, you will lead the Process Engineering function responsible for driving manufacturing excellence, process optimization, material qualifications, continuous improvement initiatives, and technology development activities. This role will be instrumental in supporting quality, cost, yield, and business continuity objectives while ensuring robust and efficient manufacturing processes.

Reporting to the Process Engineering Senior Manager, the Process Engineering Manager will provide leadership to the Process Engineering team while partnering closely with Operations, Quality, Supply Chain, Regulatory Affairs, R&D, and other cross-functional teams.

Key Responsibilities

Process Engineering Leadership

Lead and manage Process Engineering activities to support manufacturing performance, quality improvement, cost reduction, and operational excellence objectives.

Develop and execute process improvement strategies that enhance yield, productivity, efficiency, and product quality.

Establish priorities, resource plans, project schedules, and deliverables to ensure successful execution of engineering initiatives.

Drive accountability for process performance, project milestones, and continuous improvement goals.

Materials & Process Technology Management

Lead materials and process technology development activities to support product quality enhancement, cost optimization, and business continuity requirements.

Oversee compounding and catheter offline dipping equipment (CODE) operations to ensure process effectiveness, equipment reliability, and manufacturing consistency.

Manage new replacement material qualifications to support supply continuity and business sustainability.

Lead alternate material qualification projects to support cost reduction and quality improvement opportunities.

Identify and implement initiatives to reduce material waste and improve resource utilization.

Drive value engineering activities to improve product quality, manufacturing efficiency, and overall cost competitiveness.

Manufacturing Support & Continuous Improvement

Provide technical leadership and consultation on process optimization, yield improvement, troubleshooting, and quality improvement initiatives.

Support manufacturing operations through structured problem-solving, root cause analysis, and corrective action implementation.

Lead and facilitate Lean Manufacturing, continuous improvement, and operational excellence initiatives across the manufacturing organization.

Partner with Operations and Quality teams to resolve process-related issues and improve manufacturing performance.

Project & Validation Management

Manage engineering projects from concept through implementation, ensuring timely execution and achievement of objectives.

Prepare and maintain project documentation, including capital expenditure requests, design specifications, validation protocols, and technical reports.

Lead equipment, process, and material qualification activities, including IQ/OQ/PQ validation programs.

Ensure projects are completed in compliance with applicable quality, regulatory, and corporate requirements.

Cross-Functional Collaboration

Build strong partnerships with Operations, Quality, Supply Chain, Procurement, R&D, Regulatory Affairs, and Global Engineering teams.

Support new product introductions, process transfers, material changes, and manufacturing commercialization activities.

Facilitate effective communication and decision-making across multiple stakeholders and functional groups.

Develop and lead a high-performing Process Engineering team through coaching, mentoring, and performance management.

Promote a culture of accountability, innovation, collaboration, and continuous improvement.

Support talent development, succession planning, and technical capability growth within the engineering organization.

Required Qualifications

Education

Bachelor's Degree in Materials Engineering, Materials Science, Chemical Engineering, Manufacturing Engineering, Mechanical Engineering, or related discipline.

Lean Manufacturing and/or Six Sigma certification is an advantage.

Experience

Minimum 5 years of experience in process engineering, materials engineering, or manufacturing engineering within a manufacturing environment.

Experience in process optimization, continuous improvement, yield enhancement, and manufacturing troubleshooting.

Experience leading engineering projects, material qualification activities, and validation programs.

People leadership experience is preferred.

Process optimization and continuous improvement

Material qualification and validation

Lean Manufacturing and Operational Excellence

Value Engineering and cost reduction initiatives

Yield improvement and process troubleshooting

Root Cause Analysis (RCA) and structured problem solving

Statistical process control and data analysis

Project management and execution

Manufacturing process development and support

Preferred Qualifications

Experience in medical device manufacturing or highly regulated manufacturing environments.

Experience with catheter manufacturing, latex processing, compounding, or related technologies.

Knowledge of FDA, ISO 13485, GMP, and applicable regulatory requirements.

Professional certifications such as Lean Six Sigma Green Belt/Black Belt or equivalent.

Key Skills & Attributes

Strong leadership and team management capabilities.

Excellent analytical and problem-solving skills.

Effective project management and organizational skills.

Strong communication and stakeholder management abilities.

Ability to influence and collaborate across multiple functions.

Results-oriented mindset with a focus on quality, cost, and operational performance.

Passion for continuous improvement and manufacturing excellence.

Why Join BD?

At BD, you will have the opportunity to lead initiatives that drive manufacturing excellence, process innovation, and continuous improvement while contributing to products that advance the world of health™. You will work in a collaborative environment that values leadership, learning, and career growth.

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-​art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

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