Cochlear

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. Around the world, more people choose Cochlear-branded hearing 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. Learn and grow with us as we tackle the most complex challenges in helping people to Hear Now And Always.

To support the growth in Manufacturing, we have a fantastic opportunity for a Senior Manufacturing Support Engineer to work in Cochlear Malaysia. You will be responsible to maintain efficient and productive engineering support to the manufacturing /repair areas through implementation and management of day-to-day manufacturing/repair issues and process improvement. You will be also required to provide engineering support to Manufacturing and Repair cost saving activities in CMY and ensuring quality requirements are met.

In this role you will be responsible for: 

• Provide the first point of contact for Manufacturing & Repair on yield, quality and throughput issues.
• Provide solutions to identified Manufacturing & Repair problems
• Supporting NPI activities and helps ensure a smooth transition into production.
• Analyse and resolve complex Manufacturing, Quality and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Ensure NCR’s, CAPAs, Concessions and Change Notes are processed in a timely manner.
• Identify process solutions and create plans to coordinate activities and mentoring other engineers and technicians when required to progress plan.
• Ability to analyze the failures & challenges using proven method to identify the root cause and implement solution for yield & quality improvement.
• Liaise and collaborate with other departments (warehouse, supply, procurement, NPI) to resolve manufacturing challenges.
• Review product, process and equipment designs, work instruction and safety to ensure the business needs are met without compromising the quality requirements.

Key Requirements

• At least 8 years of experience in preferably in a highly regulated GMP manufacturing environment.
• Minimum Bachelor’s degree in Electrical Engineering, Technical or Manufacturing qualification
• Experience in working within a Quality Management system is highly desirable for this role.
• Experience in working within Production Management system (e.g. Oracle)
• Experience in Design of Experiment (DOE), develop protocols, perform process validations IQ/OQ/PQ is a MUST for this role.
• Experience in designing process flow and production line layouts is a MUST for this position.
• Experience in risk management (risk analysis, DFMEA, PFMEA) is highly desirable for this position.
• Experience in designing process flow and production line layouts.
• Exposure to a highly regulated environment working within a Quality Management Systems (QMS) framework – ISO exposure or good understanding of QMS is a MUST for this role.
• Knowledge in Change Management Process is highly desirable.
• Demonstrate strong Project Management skills especially in process improvement and cost saving projects are an added advantage.
• Proven competencies in problem solving, design, manufacturing / business process development and personal influence
• Good interpersonal skills and written communication in English
• Candidates from Medical Device manufacturing industry will have an added advantage.

This is your chance to be part of a premier organization with a great culture, working in a dynamic, growing and rapidly evolving environment to deliver outstanding results that benefit our customers every day. Be part of something purposeful and APPLY now by clicking on the link below and see your career grow!

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.

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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