Senior Manufacturing Support Engineer – Medical Devices

Cochlear Malaysia Sdn Bhd; Kuala Lumpur; On-site; MYR 150,000 - 240,000; Full time

Job summary

Cochlear Malaysia Sdn Bhd is hiring a Senior Manufacturing Support Engineer to bolster manufacturing and repair operations, manage day-to-day challenges, drive process improvements, and support cost-saving initiatives. You will work with cross-functional teams to boost yield, quality, and compliance while maintaining the highest standards of GMP and product integrity.

The role requires strong problem-solving, DOE and validation expertise, and the ability to mentor engineers and technicians.

Qualifications

• Minimum 5 years of experience in a GMP manufacturing environment.
• Experience with QMS framework and ISO exposure or strong understanding of quality system requirements.
• Experience with Production Management Systems such as Oracle is desirable.
• Proven experience in DOE, process validation, and developing validation protocols (IQ/OQ/PQ).
• Experience in designing manufacturing process flows and production line layouts is required.
• Knowledge of DFMEA and PFMEA methods is highly desirable.

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

Continuous improvement

DOE

Process validation

IQ/OQ/PQ

Process flow design

QMS

DFMEA/PFMEA

Data analysis

Project management

Mentoring

Communication (English)

Education

Bachelor’s degree in Electrical/Manufacturing Engineering or related field

Tools

Oracle Production Management Systems

Job description

Cochlear Malaysia Sdn Bhd is hiring a Senior Manufacturing Support Engineer to bolster manufacturing and repair operations, manage day-to-day challenges, drive process improvements, and support cost-saving initiatives. You will work with cross-functional teams to boost yield, quality, and compliance while maintaining the highest standards of GMP and product integrity.

The role requires strong problem-solving, DOE and validation expertise, and the ability to mentor engineers and technicians.