Job Overview
We are seeking a highly skilled Software Design Assurance Engineer to join our team. The ideal candidate will have a strong background in software development and quality assurance, with excellent communication skills.
Main Responsibilities:
* Provide software quality leadership for new product introductions and sustaining product development teams.
* Work closely with the software development team on process optimization for efficient iterative generation and maintenance of regulatory deliverables.
* Support the creation and review of all medical device software documentation, including software development plans, design specifications, software safety classification, software design verification testing plans, protocols, and reports, software issue tracking, and resolution, cyber security assessments, etc.
* Develop test plans and test cases based upon the product and component level requirements.
* Ensure that product development projects and changes to existing products are conducted in compliance with applicable regulations and standards, and internal company procedures.
Qualifications and Skills:
* Bachelor's degree or higher in a related field.
* 3+ years in regulated work environment, including at least 2 years in Medical Devices.
* Technical expert with strong communication skills.
* Experience with verification and validation (V&V) required.
* Expert knowledge of IEC 62304 (Software Development Life Cycle).
* Good working knowledge of ISO13485 and ISO14971.
* IEC 62366 knowledge preferred (Usability).
* Understanding of MDR and CFR requirements.
* Prior experience with Jira/Structure/templated export or equivalent software tooling.
Location: Dublin, Ireland.
Estimated Salary Range: €60,000 - €80,000 per annum