Process Engineer

Pentamaster Corporation Berhad (Official); Simpang Ampat; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical technology firm in Malaysia is seeking a skilled Medical Device Process Engineer to develop and optimize manufacturing processes. The ideal candidate will have a Bachelor’s degree in relevant engineering fields and over 3 years of experience in the medical device industry. Strong knowledge of FDA regulations and quality systems is required. This role offers a chance to impact the design and manufacturing of cutting-edge medical devices.

Qualifications

• 3+ years of experience in process engineering within the medical device industry.
• Strong knowledge of FDA regulations and ISO standards.
• Proficiency in statistical process control and improvement methodologies.

Responsibilities

• Develop and optimize manufacturing processes focusing on efficiency and quality.
• Conduct process validations and perform risk assessments.
• Prepare and maintain documentation for process specifications.

Skills

Process engineering

Problem-solving

Communication

Education

Bachelor’s degree in Biomedical, Mechanical, or Chemical Engineering

Tools

CAD software

Process simulation tools

Job description

Overview

We are seeking a skilled Medical Device Process Engineer to join our team. This role involves designing, developing, and optimizing manufacturing processes for medical devices, ensuring compliance with industry regulations and quality standards.

Key Responsibilities

• Develop and optimize manufacturing processes for medical devices, focusing on efficiency, quality, and safety.
• Collaborate with R&D, quality assurance, and production teams to ensure seamless transition from design to manufacturing.
• Conduct process validations and perform risk assessments to identify and mitigate potential issues.
• Analyze production data to identify trends and areas for improvement.
• Implement process control strategies to maintain product quality and consistency.
• Prepare and maintain documentation for process specifications, work instructions, and standard operating procedures.
• Lead root cause analysis and corrective action initiatives for process-related issues.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a related field.
• 3+ years of experience in process engineering within the medical device or related industry.
• Strong knowledge of FDA regulations, ISO standards, and quality systems.
• Proficiency in statistical process control (SPC) and process improvement methodologies (e.g., Six Sigma, Lean).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.

Preferred Skills

• Experience with CAD software and process simulation tools.
• Familiarity with materials used in medical device manufacturing.
• Project management experience is a plus.

This role offers the opportunity to impact the design and manufacturing of cutting-edge medical devices. If you are passionate about improving processes and ensuring product quality, we encourage you to apply!