Senior Manufacturing Excellence Engineer - Medical Devices

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

Cochlear Malaysia is seeking a Senior Manufacturing Support Engineer to provide engineering support across manufacturing and repair operations, drive process improvements, and support cost-saving initiatives while sustaining quality.

You will collaborate with cross-functional teams to resolve complex issues, support NPI, and ensure compliant, efficient production with strong emphasis on GMP and QMS requirements.

Qualifications

• Bachelor’s degree in Electrical/Manufacturing Engineering and GMP manufacturing knowledge.
• 8+ years in regulated medical device environment.
• Experience with DOE, validation protocols IQ/OQ/PQ.
• Strong English communication and cross-functional collaboration.

Responsibilities

• Serve as first point of contact for yield, quality, and throughput issues.
• Provide technical solutions to manufacturing and repair challenges.
• Support NPI activities and scale new products to production.
• Analyze NCRs, CAPAs, non-conformances, and audit observations.
• Identify process improvements and mentor engineers and technicians.

Skills

DOE (Design of Experiments)

Process optimisation

Troubleshooting

Project management

Quality Management System

Risk analysis

Data analysis

Interpersonal skills

Education

Bachelor’s degree in Electrical/Manufacturing Engineering

Tools

Oracle

QMS tooling

Job description

Cochlear Malaysia is seeking a Senior Manufacturing Support Engineer to provide engineering support across manufacturing and repair operations, drive process improvements, and support cost-saving initiatives while sustaining quality.

You will collaborate with cross-functional teams to resolve complex issues, support NPI, and ensure compliant, efficient production with strong emphasis on GMP and QMS requirements.