**主要工作职责** **Key Responsibilities** **:** + Lead hardware activities on assigned Supply Chain activities through to completion. + Support Product Investigations related to digital products. Identify key technical challenges and recommend solutions. + Carry out work that will deliver cost savings to the business in support of cost initiatives. + Change Management Ownership. Assess changes, write and execute Quality Management System (QMS) documentation in support of product change (e.g. Hardware Risk Specifications, Design Reports, Bill of Materials (BOM) and Schematic Circuit Diagrams, Risk Analyses, Failure Mode Effects Analysis (FMEA), Test Protocols and Test Reports. + Provide technical expertise in support of qualification and introduction of second source alternative components. + Close the loop on component shortages/obsolescence by undertaking component level risk assessment activities in support of obsolescence management. + Independently plan and perform testing of support activities, analyse technical results draw conclusions and report recommendations. + Take on additional roles/functions outside of their immediate responsibilities as required. Compliance/QMS + Regulatory Conformity & Technical Assurance: + Maintain EMC and Electrical Safety conformity, + Conduct assessments and prepare technical assurance documentation related to Restriction of Hazardous Substances (RoHS); Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); and Battery Directive. + Maintain accurate and up to date records of all work carried out in accordance with Good documentation practice (GDP). + Write and execute QMS documentation in support of any revalidation activities (e.g. Test Strategy, Risk Analysis, Test Protocol, Test Report). + Remain compliant with all H&S requirements, including Control of Substances Hazardous to Health (COSHH) and risk assessments. Manufacturing + Support Electronic Manufacturing Suppliers (EMS) acting as technical representative in support of business solutions. **任职条件** **Qualifications** : + Relevant electronics engineering or technical degree + Proficient with the regulatory requirements for in-vitro diagnostics medical devices and/or Medical Electrical (ME) equipment + Experience of working within a QMS driven environment + Proven track record of delivering support for a high-volume manufacturer of consumer digital medical devices + Competent at employing analytical techniques and solving technical problems + Excellent organisational and planning skills + Demonstrates the ability to work in a fast paced environment, as well as a flexible working approach to accommodate the changing priorities of the business + Excellent communication skills, including report writing and presentation of findings + Fluent in speaking English and Chinese + Some travels required in China and in Bedford (1 or 2 times a year) An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com