Senior Manufacturing Support Engineer

Change peoples 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 peoples lives.

Cochlears 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 industrys best clinical research and support networks. Thats 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 lifes 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 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.
• Bachelors 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 Cochlears 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.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear please start your application by clicking the apply button below.

Cochlear Malaysia provides shared services to support Cochlears 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.

If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear please start your application by clicking the apply button below.

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