• Work with engineering team to architect and write design descriptions as part of the development of a new medical device, including system architectures
• Work with an engineering and quality teams to build a software release and change management process for a Class II medical device.
• Work directly with design and engineering team to draft design documents/drawings, process instructions, test reports and protocols, device master records, test plans and reports, summaries and final reports from raw data, risk management.
• BEng in related field (Electrical, Mechanical, Mechatronics, Biomedical, Computer Science) or equivalent work experience
• 2+ years of experience working on medical device development under 21 CFR 820 and ISO 13485
• Basic project management skills and ability to manage multiple, competing priorities in a fast-paced, constantly changing environment.
• Ability to work with engineers to draft project execution documents such as device master records, hazard analysis, exploratory study plans, test protocol and reports, summaries etc
• 4+ years experience as a Technical Writer or Systems Engineer on a medical device project with hardware and software development background
• Experience in working with IEC 62304 standard
• Experience with requirements management tool
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