Senior Manufacturing Process Engineer — Medical Devices

Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia SDN BHD is seeking a Senior Manufacturing Support Engineer to drive day-to-day manufacturing challenges, support NPI activities, and implement solutions to improve yield, quality, and efficiency. You will collaborate with cross-functional teams to resolve complex issues in a highly regulated GMP environment.

The role emphasizes problem-solving, process improvements, and cost-savings while maintaining strict quality standards and compliance across manufacturing and repair

Qualifications

• Minimum 5 years of relevant GMP manufacturing experience.
• Bachelor's degree in Electrical Engineering or related field; ISO/QMS familiarity.
• DOE, IQ/OQ/PQ validation experience required.

Responsibilities

• Act as the first point of contact for Manufacturing and Repair teams regarding yield, quality, and throughput-related issues.
• Provide technical solutions to identified manufacturing and repair challenges.
• Support NPI activities and ensure smooth transition of new products into production.
• Analyse and resolve complex Manufacturing, Quality, and Compliance issues, including CAPAs, non-conformances, and audit observations.
• Ensure NCRs, CAPAs, Concessions, and Change Notes are processed and completed within the required timelines.
• Identify process improvement opportunities and develop implementation plans while coordinating activities and mentoring engineers and technicians when required.
• Apply structured problem-solving methodologies to analyse failures, identify root causes, and implement effective solutions to improve yield and quality.
• Collaborate with cross-functional teams including Warehouse, Supply Chain, Procurement, and NPI to resolve manufacturing challenges.
• Review and improve product, process, equipment designs, work instructions, and safety requirements to ensure business objectives are achieved without compromising quality.
• Support manufacturing and repair cost-saving initiatives while ensuring compliance with quality requirements.

Skills

Troubleshooting

Structured problem-solving

DOE

Process validation

Quality systems

Cross-functional collaboration

Project management

Education

Bachelor's degree in Electrical Engineering

Manufacturing Engineering

Tools

Oracle

Job description

Cochlear Malaysia SDN BHD is seeking a Senior Manufacturing Support Engineer to drive day-to-day manufacturing challenges, support NPI activities, and implement solutions to improve yield, quality, and efficiency. You will collaborate with cross-functional teams to resolve complex issues in a highly regulated GMP environment.

The role emphasizes problem-solving, process improvements, and cost-savings while maintaining strict quality standards and compliance across manufacturing and repair