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.
About the Role
We are looking for a Senior Product Lifecycle Engineer to support the ongoing development, improvement, and compliance of our medical device products. In this role, you will plan and execute sustaining engineering activities, ensure product compliance with international regulations, and lead risk management documentation for existing products.
You will also play a key role in supporting local production, coordinating design changes, and collaborating with global R&D teams. This position is ideal for an engineer who enjoys problem-solving, cross-functional teamwork, and maintaining high standards of product quality and safety.
You’ll be part of a global Product Lifecycle Engineering (PLE) department partnering closely with Mechanical Engineers, Electronics Engineers and Project Managers, to sustain Cochlear’s product portfolio.
Key Responsibilities
1. Risk Management & Regulatory Compliance
Maintain and update product risk management files in accordance with ISO 14971 and other medical device standards.
Plan, execute, and document product risk management activities.
Support certification and re-certification processes to ensure ongoing regulatory compliance.
Report and escalate potential product risks; ensure all identified risks are reduced to acceptable levels.
Collaborate closely with the Systems Risk Management team to align with best practices.
2. Engineering & Technical Support
Provide engineering expertise and support for local production, by collaborating with global R&D and PLE teams to resolve.
Provide engineering support across functions including R&D, Manufacturing, Regulatory, Procurement and Quality.
Lead sustaining engineering activities such as investigations, design changes, and documentation updates.
Prepare and maintain engineering documents, test plans, and verification reports.
Conduct or oversee verification testing to ensure device safety and performance.
Coordinate prototype procurement, build trials, and technical analysis (DFMEA, design reviews, etc.).
3. Project Execution & Collaboration
Plan, organise, and deliver sustaining projects within defined time, budget, and quality targets.
Manage stakeholders effectively across multiple departments, including R&D, Manufacturing, Regulatory, Procurement and Quality.
Coordinate with internal and external partners to resolve technical issues and meet project milestones.
4. Communication & Continuous Improvement
Take proactive ownership of assigned tasks and deliverables.
Communicate clearly and effectively across teams and levels.
Build strong working relationships with cross-functional stakeholders and external suppliers.
Adapt quickly to shifting priorities and contribute to process and product improvements.
Key Requirements (Minimum):
Bachelor’s Degree in Engineering (Biomedical, Mechanical, Electrical, Systems or related).
Possess minimum 4–6 years’ experience in product development, sustaining engineering, or related experience within the medical device industry.
Understanding of, and experience in, product risk management principles, methods and tools that are appropriate for the development of medical devices (FMEA, Hazards Analysis, Risk Management Plans and Reports).
Experience in Mechanical engineering design and verification, preferably with electro-mechanical products.
Ability to interpret and modify mechanical designs, assemblies, and technical drawings.
Experience with mechanical CAD software tools (e.g., Creo, SolidWorks or similar).
Ideal to have:
Understanding of/and experience in mechanical and systems engineering methods and tools that are appropriate for the development of medical devices.
Experience in regulated industry such as medical devices, defense, automotive.
Experience in the application of ISO14971 Risk Management for Medical Devices.
Experience in the application of IEC60601-1 Medical Electrical Equipment Safety Requirements.
Experience in the application of EN45502 Active Implantable Medical Device Requirements.
Knowledge of Geometric Dimensioning and Tolerancing (GD&T).
Demonstrated experience with laboratory equipment used to measure part geometry e.g. Smartscope or similar.
Experience using collaborative software tools e.g. JIRA, Confluence or equivalent.
Exposure working with MNC (multi-national corporation) organisation is highly desirable.
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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