Senior Manufacturing Support Engineer

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; Sur place; MYR 180 000 - 240 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

DOE (Design of Experiments)

Process optimisation

Troubleshooting

Project management

Quality Management System

Risk analysis

Data analysis

Interpersonal skills

Formation

Bachelor’s degree in Electrical/Manufacturing Engineering

Outils

Oracle

QMS tooling

Description du poste

Change people’s lives and love what you do! Cochlear develops world-leading medical devices that help people hear. As a top 100 medical device company and market‑leader in implantable hearing devices, more people choose a Cochlear‑branded cochlear implant system than any other. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives. Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.

The Opportunity To support the continued growth of Manufacturing at Cochlear Malaysia, we are seeking a highly skilled and experienced Senior Manufacturing Support Engineer to join our team. In this role, you will provide effective engineering support to manufacturing and repair operations by managing day‑to‑day manufacturing challenges, driving process improvements, and supporting cost‑saving initiatives. You will play a key role in ensuring manufacturing efficiency, productivity, and compliance while maintaining the highest quality standards. You will collaborate closely with cross‑functional teams to resolve complex manufacturing issues, support new product introduction (NPI) activities, and implement solutions that improve product yield, quality, and operational performance.

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.
• Experience with Branson ultrasonic welding equipment will be considered an advantage.
• 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 8 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.