- Be part of the cross-cultural team driving Product Development of Medical devices from concept to production, including translation of product requirements to technical specifications, definitions of product hardware architecture, review and selection of key technologies, performing design reviews to assess robustness, product debug and validation and resolving issues.
- Conduct Hardware and Electronic development to meet design requirements in terms of functionality, reliability, cost and compliance to industry standards. Must be sensitive to cost during the architecture phase and able to propose trade-offs between cost, quality and functionality. Plan schedule, estimate level of effort and man hour.
- Responsible for design, implementation, integration, debugging, verification and validation testing of hardware modules for product development. Conduct prototype design simulation using suitable software platforms. Create test plan and test cases for Hardware verification. Create validation requirements documents, generate and execute high/low level unit/integration test plans.
- Responsible for the software development life cycle (project planning, software test requirements/strategy definition, software verification/validation and software quality assurance)
- Software verification/validation testing – create test plan and test cases. Generate and execute high/low level unit/integration test plans. Review the test result and lead the root cause analysis in troubleshooting activities. Support continuous improvement in the software validation process and methods.
- Support Software quality assurance – Perform code reviews. Outline corrective action for given issues and problems. Ensure the software meets Project requirements. Ensure Regulatory compliance is fully met with proven design solutions and design practices.
- Degree or Master in Electrical & Electronic Engineering or equivalent experience.
- At least 3 years working experience in Product development for Medical device
- Design experience in complex electromechanical products is an advantage. Other relevant experience include Optical sensor components (Light Emitting Diode/Photo detector), Electro-mechanical components and embedded system design.
- Possess IEC61010, IEC62304 and ISO138485 knowledge.
- Able to handle laser class 3b equipment.
- Strong EMC knowledge and design countermeasure.
- Working knowledge of CAD tools, including Altium Designer, PCB design and layout tools.
- Conversant with DFx and quality concepts including designing for manufacturability, verification and reliability testing and regulatory requirements.
- With hands on experience on hardware prototyping (testing & evaluation)
- Familiar with firmware development on embedded systems using C/assembly.
- A committed, competent and self-motivated team player with outstanding analytical and problem solving skill, strong verbal, written communication and excellent communication/presentation skills for interfacing with other Project team members.