Sr. Electrical Engineer
Sr. Electrical Engineer
The Electronics Engineer is responsible for technical realization of a product release/lifecycle management. The scope includes translation of user requirements, requirements management, technical approach, design specification and interfaces, feasibility of potential solutions, allocation of derived requirements and traceability, design reviews, integration coordination, technical liaison to the program, technical roadmap, defect management/root cause analysis and risk management.
Key Areas of Responsibility:
- 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.
- Design process compliance assurance, design quality assurance and design reviews
- Technical management of medical device and components during product life cycle.
- Design risk management
- Defect management
- Bachelor of Science in Systems, Electrical, Computer Science, Physics, Biomedical Engineering or equivalent degree in a Scientific/Engineering discipline.
10+ 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.
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