14 of 14 ISO 13485 Jobs in the South East

full software development lifecycle, including requirements definition, architecture, implementation, testing, risk, cybersecurity and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, ISO 14971 and other relevant safety standards. Establish and enforce high-quality software design control practices, including code reviews. … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

relevant machinery safety standards and company policies. Conduct risk assessments and implement safeguarding measures for automated equipment. Support compliance with quality management systems, including ISO 9001 and ISO 13485 where applicable. Maintain accurate engineering documentation, including electrical drawings, specifications, and validation records. Qualifications & Experience Essential Degree ...

short notice. Support product testing and validation during New Product Introduction (NPI). Complete build sheets, QA records and validation documentation in line with ISO 13485 and ISO 9001 requirements. Maintain test equipment calibration and process spare parts returns. Support Field Service Engineers on customer sites once ...

part of the role Experience of line management, supervision or mentoring of technical, manufacturing or workshop-based staff Desirable Criteria Experience of quality auditing, ISO 9001, 13485, or similar, supplier management, line management or regulated manufacturing environments Experience of CAD, rapid prototyping, product development and collaboration with design ...

room HVAC system and all associated filtration and ducting to ensure the clean room remains compliant to ISO7 standard in accordance with BS EN ISO 14644. Recruit, train and mentor a small team of maintenance technicians, when required, to be competent in all clean room and equipment maintenance activities. … systems designed to function within an ISO7 clean room. Experience of working within an organisation certified to one or more of the following standards: ISO 9001, AS 9100, ISO 13485, IATF 16949. Proficiency in Microsoft Office (or equivalent), for using spreadsheets and generating written documents. Ability ...

considerations and design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross ...

bring The essentials: Degree in Electronics Engineering, Electrical Engineering, or related discipline. Proven experience in electronics design for medical or regulated devices (ISO 13485 environment preferred). Proficiency in Altium Designer for schematic capture and multi‐layer PCB layout. Strong understanding of STM32 microprocessors, BLE, power/battery … Familiarity with DFM/DFT principles and working with contract manufacturers. Understanding of wireless regulatory testing (CE/FCC) and EMC design. Knowledge of ISO 14971 risk management and medical device development processes. Embedded systems development experience. Why Neupulse? Make a tangible difference. Your work on cutting‐edge wearable ...

. Qualifications: Degree in Mechanical, Electrical, Mechatronics, or Automation Engineering (or equivalent hands-on experience). Pluses: Robotics integration (6-axis/SCARA), ISO 13485/GAMP knowledge, or Six Sigma training. ...

framework. Training and mentoring junior members of the team. Promote automation-first thinking within the testing team. Compliance with the MDD/MDR and ISO 13485/62304 standards for validation and verification of software medical devices. Skills & Experience Required: Essential Strong Python programming skills, including object-oriented ...

statistical acceptance criteria and data-driven testing. Biomedical, healthcare or digital-health experience. Experience in regulated medical technology environments. Familiarity with IEC 62304, ISO 13485 or related medical-device standards. We do not require previous experience specifically in hardware or embedded-software testing, web front-end testing, clinical ...

ability to assess and improve working practices within the Warehouse. Competence in Vitalograph procedures and the Quality Management System (QMS). An understanding of ISO 13485, the Medical Devices Directive and GCP, as required. If youre looking for a hands-on role where you can develop your technical ...

speed, and extend coverage across tests for medical device software validations. You will mentor juniors and promote automation-first practices while aligning with ISO 13485/62304 compliance requirements. #J-18808-Ljbffr ...

other cancers a plus) International experience (work or study abroad) esp in North America, Europe and APAC Experience working within regulated environments (e.g. ISO 13485) What we offer Work that is both challenging and rewarding and has a real positive impact on people's lives Fast growth, ownership ...