9 of 9 Permanent ISO 13485 Jobs in the Thames Valley

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 ...

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 ...

. 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. ...

data using analytical and statistical methods. (desirable) Degree in STEM related subject. Early career experience within a regulated or technical environment (desirable) Exposure to ISO 13485 or laboratory quality systems. (desirable) Experience with mechanical testing or laboratory instrumentation. (desirable) Interest in medical devices and combination products.(desirable) What ...

also possess previous experience in: Experience in one or more: cell culture, media development, bio-processing, life science, as well as familiarity with ISO 13485 Proficient with project management principles (e.g., resource allocation, cost estimation, risks analysis) & project management tools and applications software to manage complex project timelines. ...

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 ...

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 ...

/Clinical industry. Strong project and resource management skills with ability to manage multiple projects. Experience working with Quality Framework (ISO) standards (e.g.ISO27001, ISO13485) and ICH GCP, and understanding of 21 CFR Part 11 regulation. Proactive, analytical, and problemsolving skills with commitment for continuous improvement. #J-18808-Ljbffr ...