Senior Electronics Engineer
In this role, you have the opportunity to
Coordinate with PMO, PE and cross-functional team to execute Value Engineering and Quality/Availability/Cost improvements. In-scope products will include patient monitors, medical consumables and accessories, and potentially any products in MA.
You are responsible for
- Overall technical responsibility for realization of a new product or component release or sustaining activity – leading the analysis, design, test, troubleshoot, document of internal or supplier mechatronic systems and/or sub-systems.
- Translation of user requirements, regulatory requirements, manufacturing requirements, service requirements, process requirements into device and component requirement specification, interface speciation, and top level device and component design.
- Requirements management, decomposition of derived requirements, feasibility of potential solutions, design options and decision, verification and validation planning and design.
- Leading or develop new and optimize existing product concepts within cross-functional teams, or leading and controlling outsourcing of these activities, and aligned with R&D development project roadmap.
- Build prototypes for feasibility, functionality, and performance assessments.
- Develop design output, from schematics, BOM, to dFMEA, DFT, DFM, risk management, verification & validation plans and reports, etc.
- Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g. IEC 60601-1, IEC 60601-1-2, ISO 14971, FDA cGMP, QSR, ISO 13485, EU MDR).
- Design process compliance assurance, design quality assurance. Lead design reviews and EC process.
- Technical management of medical device and components during product life cycle.
- Design risk management
- Defect management
You are a part of
A professional R&D team with around 70 team peers in Shenzhen China.
To succeed in this role, you should have the following skills and experience
- Bachelor of Science in Systems, Electrical, Computer Science, Physics, Biomedical Engineering or equivalent degree in a Scientific/Engineering discipline.
- 8+ years of experience in an engineering role beyond the educational qualification.
- Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1 and ISO 14971.
- Proven excellence in technical leadership in a matrix environment, including demonstrated ability to influence indirect resources.
- Design control process management track record
- Working knowledge of tools and processes related to system configuration management from specifications development, traceability, version control, defect tracking and field feedback.
- Knowledge and experience spanning multiple engineering disciplines (e.g. mechanical, software and systems engineering).
- Demonstrable clear oral communication, as well as well-organized documentation skills; excellent command of written and spoken English.
- Ability to drive solutions and decisions in a cross-functional team environment.
- Experience in requirements management tool, design quality management tools, risk management tools, and problem reporting/defect tracking tools.
- Hands on experience on FMEA, Fault Tree analysis, Reliability block diagrams preparation and RCA techniques, design and simulation tools and CADs.
- Demonstrated capability to conduct and lead technical reviews of product design elements.
- Demonstrated ability in leading evolution of a complex feature, where analysis requires both evaluation of multiple candidate solutions and significant evaluation of intangibles.
In return, we offer you
A promising professional career development platform. Work in the medical industry brings much fulfillment, as well as unique challenges; you will be empowered to drive groundbreaking innovations with a globally recognized, premium brand behind you.
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