Nairn, Scotland, United Kingdom
A driven, enthusiastic, and initiative-taking Electronics and Firmware Engineer, with 20 years’ analogue and digital electronics design experience. 13 years have been spent as a technical specialist in low power IVD and Wearable sensor electronic device development, and as subject matter expert in RF, EMC and Safety testing; documenting, testing and certifying numerous medical devices for worldwide launches according to ISO15197, 61010, 61326, 60601 and Bluetooth SIG Certification. Hands-on experiencing of developing ISO 13485 Quality Management Systems for Medical start-ups. Experience, knowledge and understanding of the full product lifecycle. Experienced technical project lead and project manager with extensive practical knowledge developing and executing project plans, requirements gathering and generation, developing and executing test plans, producing dFMEA, recording and maintaining all aspects of device design, manufacturing data, running CAPAs and Cost Improvement Programs across a range of products. Has led on numerous different types of hardware and firmware projects, with many different team sizes from large 50+ teams, to working as an individual. Some of the types of projects worked on include; High volume Blood Glucose Medical Device development, Wearable sensors, Implants, Military/Government high value - low volume products, Wireless based (LPWAN, 4G, Bluetooth, Wi-Fi, EnOcean and Zigbee) devices, IOT and Industrial monitoring and control (Ethernet/ RS485/ BACnet and Modbus).
Electronics and Software Design Services
Performed a role beyond that of a traditional electronics engineer. Undertook the core responsibilities as a medical electronics engineer; Developing Waire Health’s state of the art wearable sensors utilising the latest Altium design tools and managing the companies BOM structure and component selection, but as a medical device design expert, acted as a core member of the management team, performing technical project management activities, undertaking planning and resource management, and leading the company’s requirements, risk, usability, quality, regulatory, design verification, packaging and labelling activities. Line Manager for another Electronics Engineer.
Part of an R&D team who were developing the next generation of battery powered blood glucose monitoring devices. Dealing with a large variety of people to perform the role both within the UK and abroad. Experience of maintaining good documentation, completing thorough design documentation utilizing QMS systems (Master Control), dFMEAs, CAPAs, test plans, and test reports. Regularly travelled across the World to support manufacturing of LifeScan’s medical devices and conducting regulatory testing. Company’s subject matter expert with regards to World RF Regulatory testing of Bluetooth devices, and performed technical supplier audits in China. Developed Analogue and Digital electronics using the latest Altium design suite.
At t-mac Technologies Ltd. had sole responsibility for all new product designs as well as the maintenance of existing product lines. Created all electronic designs using the latest design packages and collaborated closely with a team of embedded engineers to develop a range of different products. t-mac manufactured all their products on site, which meant that I was responsible for the regulatory certification and design for manufacture of all their products, including the development of all test equipment. This included programming P+P machines, creating manufacturing and end user documentation and working closely with the Production manager on all new designs. Worked daily managing a small team of engineers, contractors and supporting end users. Was t-mac's primary trainer for installers and customers, and regularly traveled around the UK to assist with customer installations and to provide on-site training.
Extensive exposure to Military and Defense based projects. Held SC clearance.