Principal Software Engineer - Design Assurance

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.

Responsibilities

·      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

Requirements

·      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.

For an immediate interview, please click the apply button below!