可替代职业名称:Electronics Test Engineer, Product Engineer, Product Development, or related
是否为正常职业要求:Y
是否需要外语:N
特殊技能:Masters or foreign equivalent degree in Electrical Engineering or in a closely related engineering field of study Will accept a Bachelors degree 5 years of related progressive professional product development experience in lieu of a Masters each alternative requirement with at least 2 years of professional experience in i analogdigital Printed Circuit Board PCBA tests, fabrication, assembly, and quality engineering for medical device products; ii Class II and Class III medical product and testing development; iii creating validation protocols including Installation Qualification IQ, Operational Qualification OQ, and Performance Qualification PQ; iv 5 Whys, Fishbone, andor other root cause analysis methods; v C, C, Python, andor related scripting languages; vi FDA, ISO, and IEC Design Control standards and requirements, including 21 CFR 820, ISO13485, ISO14971, and IEC 606011; vii initiating and completing CAPA processes; and viii managing software consultantscontractors. Employer will accept any suitable combination of education, training, or experience.