PROCESS ENGINEER (MEDICAL DEVICE)

Pentamaster Corporation Berhad; Batu Kawan; On-site; MYR 90,000 - 125,000; Full time

Job summary

Pentamaster Corporation Berhad in Malaysia seeks a process engineer to lead the end-to-end transfer of medical device products from external partners to the manufacturing facility, ensuring smooth transitions and strict regulatory compliance.

You'll drive DoE, Six Sigma, and Lean initiatives, develop and validate processes, and coordinate cross-functional teams to ensure quality and on-time product introductions.

Qualifications

• Bachelor's degree in engineering (Mechanical, Electrical, Biomedical, Industrial) or related field.
• 3–5 years of experience in manufacturing or project management, preferably in medical device assembly.
• Experience with design controls, validation protocols (IQ/OQ/PQ), and risk management.

Responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters.
• Create documentation to support new and improved manufacturing processes.
• Use Six Sigma, Lean, and Mistake proof methodologies to implement lean, capable processes.
• Manage new products implementation including BOM and Work Instruction creation, validation run activities coordination.
• Execute process validation (IQ, OQ, PQ) and validate methods for inspection and process controls.
• Collaborate to ensure proper documentation for quality systems requirements (GOIs, BOMs, Routers, FMEAs, etc.).
• Coordinate and execute engineering change workflows and document updates per SOP.

Skills

Process development

Design of Experiments

Six Sigma

Lean manufacturing

FMEA

CAPA

IQ/OQ/PQ

Documentation

Quality systems

Education

Bachelor's degree in Engineering

Job description

The process engineer will be responsible for managing the end-to-end transfer of medical device products from external business partners to our manufacturing facility. This role involves overseeing the transition of manufacturing processes, ensuring compliance with industry standards, and coordinating cross-functional teams to facilitate smooth and efficient product transfers.

Key responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.
• Create documentation to support new and improved manufacturing processes.
• Use of Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are 'born lean and capable'.
• Manage new products implementation including new BOM and Work Instruction creation, validation run activities coordination.
• Execute process validation (IQ, OQ, PQ) and validate methods for inspection for verification and process controls during product development stage, perform data analysis and report compilation.
• Collaborate to ensure proper documentation is completed to meet quality systems requirements (e.g., GOIs, BOM's, Routers, FMEA's, etc.).
• Coordinate and execute all relevant engineering change work flow, drawing and documentation update in accordance to the SOP.

About you

Bachelor's Degree (minimum) in Engineering (Mechanical, Electrical, Biomedical, Industrial), or a related field.

Medical device experience including familiarity with FDA regulations (e.g., 21 CFR 820), ISO standards (e.g., ISO 13485, ISO 14971), and other applicable medical device manufacturing standards.

At least 3-5 year(s) of working experience in manufacturing or project management, preferably in medical device assembly industry.

Process Development; equipment validations and process characterization and validation experience.

Quality Assurance/Control Experience: Understanding of design controls, validation protocols (IQ/OQ/PQ), and risk management methodologies.

Experience ensuring that products meet all quality and regulatory requirements throughout the transfer process.

Experience with failure mode analysis (FMEA), root cause analysis, CAPA (Corrective and Preventive Actions), and risk management processes.

Strong background in process design, process optimization, and troubleshooting during scale‑up.

Understanding of medical device manufacturing processes and equipment, including assembly, sterilization, packaging, and labeling.

Expertise in writing, reviewing, and maintaining SOPs, work instructions, and manufacturing documentation.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world‑class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi‑automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high‑end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost‑effective solutions, timely delivery & positioned for greater growth.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back‑end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value‑added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world‑class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi‑automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high‑end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost‑effective solutions, timely delivery & positioned for greater growth.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back‑end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value‑added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.

PENTAMASTER CORPORATION BERHAD, a Malaysian investment holding company listed on the Main Board of Bursa Malaysia Securities Berhad, is one of the global leaders in providing advanced, world‑class manufacturing automation solutions & services to help worldwide customers meet their productivity challenges & maintain the edge required for success in a competitive business environment.

Through our subsidiaries, we provide an integrated range of innovative services in technological solutions, manufacturing of automated & semi‑automated machinery & equipments, designing & manufacturing of precision machinery components, as well as design, assembly & installation of computerized automation systems & equipments.

With more than 25 years of experience in dealing with high‑end technology companies across worldwide markets, we are confident to compete in terms of manufacturing flexibility, quality services, cost‑effective solutions, timely delivery & positioned for greater growth.

History

Check our website http://www.pentamaster.com.my under 'Milestones'

Product & Services

Standard Semiconductor Back‑end Equipment. Customized Automated Solutions. Vision Inspection System. Material Handling Solutions. Test and Measurement System. High Precision Components Manufacturing. Equipment Contract Manufacturing. Shopfloor Management System. RFID Application Solutions. Logistics and Warehouse Solutions.

Vision

To provide world class automation solutions to the Manufacturing Industries in the Global Market

Mission

We are dedicated in delivering high quality and cost effective products with value‑added services. In our effort to meet our mission, we strive to provide benefits and satisfaction to our customers, vendors, employees and the community as a whole.