Senior Engineer / Engineer Manufacturing Support

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Job summary

Cochlear Malaysia provides shared services to support Cochlear’s global operations, including manufacturing and repair support in a GMP environment. The role focuses on resolving yield, quality, and throughput issues while driving continuous improvement and NPI transitions.

The ideal candidate brings 5+ years in GMP manufacturing, strong DOE and validation experience, and proven project management, mentoring, and cross-functional collaboration skills in English.

Qualifications

• Minimum 5 years of relevant experience in a GMP manufacturing environment.
• Experience with Design of Experiments (DOE), validation protocols IQ/OQ/PQ, and process validation.
• Strong knowledge of risk tools including DFMEA and PFMEA, and Change Management exposure.
• Excellent written and verbal English communication skills.

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 timelines.
• Identify process improvement opportunities and develop implementation plans while mentoring engineers and technicians.
• Apply structured problem-solving methodologies to analyse failures and implement 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 meet objectives.

Skills

Troubleshooting

Continuous improvement

DOE

Process validation

Root cause analysis

Project management

Mentoring engineers

Cross-functional collaboration

Education

Bachelor’s degree in Electrical Engineering

GMP/QMS experience

Tools

Oracle

Job description

Key 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.

Position‑Specific Skills and Challenges

• Strong ability to troubleshoot and resolve complex manufacturing, quality, and process‑related issues using structured problem‑solving techniques.
• Experienced in driving continuous improvement initiatives, process optimisation, and cost reduction projects.
• Strong knowledge and hands‑on experience in Design of Experiments (DOE), process validation, and validation protocols including IQ/OQ/PQ.
• Ability to develop and improve process flows, production line layouts, and manufacturing systems.
• Experience managing manufacturing challenges within a highly regulated Quality Management System (QMS) environment.
• Skilled in risk management practices including risk analysis, DFMEA, and PFMEA.
• Ability to interpret manufacturing data, analyse failures, and implement sustainable corrective and preventive actions.
• Strong project management skills with the ability to coordinate activities across multiple functions.
• Ability to influence, mentor, and support engineers and technicians to achieve operational goals.
• Effective communication skills with the ability to collaborate across technical and business teams.

Qualifications & Experience

Minimum 5 years of relevant experience, preferably within a highly regulated GMP manufacturing environment. Bachelor’s degree in Electrical Engineering, Manufacturing Engineering, Technical discipline, or a related field. Experience working within a Quality Management System (QMS) framework, with ISO exposure or strong understanding of quality system requirements. Experience with Production Management Systems such as Oracle is desirable. Proven experience in Design of Experiments (DOE), process validation, and developing validation protocols (IQ/OQ/PQ) is required. Experience in designing manufacturing process flows and production line layouts is required. Knowledge and experience in risk management methodologies, including DFMEA and PFMEA, is highly desirable. Experience with Change Management processes is desirable. Strong background in problem-solving, manufacturing process development, business process improvement, and stakeholder influence. Excellent interpersonal skills and strong written and verbal communication skills in English. Experience within the Medical Device manufacturing industry will be an advantage.

Cochlear Summary

Cochlear Malaysia provides shared services to support Cochlear’s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering. Our growth is creating great opportunities! Our team is expanding and we want to hire the most talented people we can. Continued success depends on it. We are the global leader in implantable hearing solutions. We have provided more than 600,000 implantable devices, helping people of all ages to lead full and active lives. We help people hear and be heard. We empower people to connect with others and live a full life. We help transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes.