5 of 5 DemandTrendPermanent ISO 13485 Jobs in Cambridgeshire

with the quality/regulatory team to ensure customer complaints, feedback, incidents and notifiable events are handled in accordance with the company's procedures for post-market surveillance (under ISO 13485 and EU MDR). Work closely with the software, firmware, hardware, operations and quality teams to resolve technical issues promptly and to ensure a positive customer experience … or other relevant data-oriented discipline (or equivalent industrial experience) Experience working with medical devices that include a software or firmware component Experience working within a quality management system (ISO 13485 or ISO 9001), or in a regulated industry Industrial experience as Tier 2 or 3 Technical Support Engineer or similar role Experience in an early-stage More ❯

code from general requirements. Experience with IoT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc). Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least 3-5 years of industrial experience in More ❯

STM32). Familiarity with RTOS, bare-metal, or embedded Linux environments. Professional experience utilising Docker containers. Experience with communication protocols (UART, SPI, I2C, USB). Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820. Strong understanding of software development lifecycle and version control (e.g., Git). Qualifications Bachelor's or Master's degree in computer More ❯

level driver development. Strong understanding of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

pragmatic, can-do attitude Comfortable working across teams in a fast-moving, multidisciplinary environment Well-organised, detail-oriented, and driven to see complex projects through to completion Experience with ISO 13485 or similar regulated manufacturing is a big plus Who you'll work with: Our Director of Cartridge Manufacturing and Programme Managers Cross functional teams including engineers, technicians More ❯