Senior R&D Electronics Engineer
Our client, a high potential medical device startup, is currently seeking a Senior Electronics Engineer to join their team.
Reporting to the Electronics Engineering Director, the Senior Electronics Engineer will provide technical leadership across all stages of development of electronic systems for medical devices, including design, testing, manufacturing, and documentation.
Role/Responsibilities: Development of electronics systems for medical devices, including:Architecture definitionRequirements specificationPrototype designRisk assessment, DFMEAManufacturing specificationSchematics and Bill of Materials creationPCB designEMC testing and troubleshootingInteraction with and/or management of external contractors/suppliersSupport preparation of compliance package for product certification, including:IEC 60601-1 and IEC 60601-1-11 (Basic Safety and Essential Performance)IEC 60601-1-2 (Electromagnetic compatibility)Support product verification activities, including:Creation of verification plan, verification protocols, and test methodsCoordinate test execution (both internally and with external test houses)Creation of verification reportsSupport preparation of budget for development activitiesProject-manage development items to ensure that all commitments are achieved within aggressive timelines while meeting agreed budget.Ensure full compliance with all Quality, Regulatory, Health and Safety procedures.Support design transfer to manufacturing.Provide effective internal and external communications and reporting.Train, develop, and lead R&D engineers and other technical staff.
Assign tasks and provide support and assistance to the development team.Engage with the QMS to ensure delivery of the overall quality strategy and support the achievement of the business quality objectives. Skills/Experience: Minimum Bachelor's Degree in Electronics/Electrical Engineering5+ years previous experience, preferably in a Medical Devices environment with knowledge of medical device product development, certification, and manufacturing processesKnowledge of RF and radio and associated standards and certification processes is desirableHighly competent in the design of Analog and Digital ElectronicsHighly experienced in the use of tools for Electronics Design (schematics capture, PCB design, etc.)
– OrCAD platform preferredHighly experienced in electronics testing/troubleshootingExperience with Electronics manufacturingCompetent with RF technologiesKnowledge of IEC 60601-1 standard series (including IEC 60601-1-2 (EMC) and IEC 60601-1-11 (Home use devices))Working knowledge of IEC 62304 desirableExperience in EMC testingExperience with firmware (C/C++ coding) desirableHigh level computer skills including Microsoft Excel, PowerPoint, Word, and MS ProjectExperience working in an Agile manner with Jira, Confluence, or similar desirable
For further information, contact James Cassidy at ****** or call in confidence at 086 0204322.
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