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 degreeProficient with the regulatory requirements for in-vitro diagnostics medical devices and/or Medical Electrical (ME) equipmentExperience of working within a QMS driven environmentProven track record of delivering support for a high-volume manufacturer of consumer digital medical devicesCompetent at employing analytical techniques and solving technical problemsExcellent organisational and planning skillsDemonstrates the ability to work in a fast paced environment, as well as a flexible working approach to accommodate the changing priorities of the businessExcellent communication skills, including report writing and presentation of findingsFluent in speaking English and ChineseSome travels required in China and in Bedford (1 or 2 times a year)