PRINCIPAL SOFTWARE ENGINEER – DESIGN ASSURANCE
Our client, a multinational company in Galway is looking for a Principal Software Engineer – Design Assurance. The successful candidate will be responsible for various software quality assurance functions during the development lifecycle of complex electro-mechanical medical devices. This company offers a competitive salary and flexible benefits package.
· Responsible for various software quality assurance functions during the development lifecycle of a complex electro-mechanical medical devices.
· Responsible for development of test strategies, test plans and test procedures.
· Participate in design and code reviews, analysis and will support the development of documentation required for FDA device approval.
· Provide leadership/guidance and coordinating test activities, schedule and resources, incident management and tracking – for both on and off site test resources.
· Monitor test results and check exit criteria. Adjust test planning based on test results and progress. Introduce suitable metrics for test progress and quality of testing and product software
· Create test reports suitable for submission to regulatory authorities to demonstrate that software is verified/validated, and all requirements are met.
· Provide guidance on software regulations to development teams.
· Responsible for ensuring that the software development process follows established procedures, standards and plans. And the risk associated with the software is identified, analyzed and managed appropriately.
· Participate in risk analysis activities as Software representative, to ensure all risks are identified and reduced as low as possible
· Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
· Working knowledge of IEC 62304 Medical Device Software
· May have broad knowledge of project management.
· Requires a Bachelors Level 8 degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
· Effective communication skills – distill complex issues into concise and clear messages
· Completes documentation and procedures for installation and maintenance.
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