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Senior Electronics Engineer

2 months ago


High Wycombe, Buckinghamshire, United Kingdom Cpl Life Sciences Full time
Job Description

The Senior Electronics Engineer will report to the Head of R&D, and work closely with the R&D Engineer, to be the primary source of electronics expertise within the Company. Their primary focus will be to work closely with external collaborators and key internal functions, including manufacturing, regulatory, and commercial, with the key objective of enhancing product performance and reliability to meet customer and market needs, and to comply with relevant regulations and optimize for manufacturing.

Key Responsibilities:
  • Work with Manufacturing on scale-up, technical aspects of supplier selection, new component, second sourcing, and validation, and visiting subcontractor facilities as necessary.
  • Provide support for and development of Automated Test Equipment for PCB programming and test, plus support for and development of Automated End of Line test equipment for finished devices.
  • Oversee the diagnosis of product complaints received, identifying the root causes of any problems. Ensure all analysis and resultant actions are systematically captured in the CAPA system.
  • Undertake full verification testing and validation of existing products and new components for product enhancements, and complete follow-up actions and any relevant manufacturing documentation.
  • Manage the end-to-end delivery of product enhancement projects, especially relating to electronic circuits, components, and systems, including verification, documentation for the company quality system, and transfer to manufacturing, implementing any necessary design changes.
  • Drive the digital electronic design component of current and next-generation wearable medical devices, including PCB design and layout, microprocessor electronics, and related software, undertaking testing of hardware and software components as necessary.
  • Work with other team members to manage all inputs and analyses required for the Company's technical files, liaising closely with the Company's regulatory function.
  • Keep up to date with the latest technology trends in electronic engineering, bringing them to bear where appropriate.
Requirements:
  • Knowledge of a range of relevant disciplines, especially PCB layout and design, but also physics, digital electronics, electrical engineering, and biomedical engineering.
  • Formal graduate-level qualifications and at least 4 years of relevant practical experience.
  • Experience in product design and development, preferably in the context of the medical devices industry, and a good knowledge of all relevant regulations that pertain to medical devices and an understanding of the clinical setting for devices.
  • Some experience of developing electronics for medical devices, preferably with specific experience of generating efficiencies in production cost, space utilization, and power consumption.
  • An appreciation of the requirements of factory-based volume manufacturing.
  • Good project planning abilities and effective team working with good collaboration and influencing skills.
  • Root Cause analysis, Ishikawa diagrams.
  • Understanding of the context of their role within the commercial objectives of the company, and the necessary degree of pragmatism, flexibility, and sense of urgency to succeed in a small company environment.