Job Summary
We are seeking a highly skilled Software Design Assurance Engineer to join our team in Dublin. Our client is a global medical technology company dedicated to establishing bimodal neuromodulation as a new standard of care for tinnitus, affecting 15% of the global adult population.
Key Responsibilities
* Provide software quality leadership for new product introductions and sustaining product development teams.
* Work closely with 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.
* Understand all aspects of the QMS related to design controls.
* Ensure that product development projects and changes to existing products are conducted in compliance with applicable regulations and standards, and internal company procedures.
* Provide detailed assessments of impacts for design changes on commercialized products.
* Utilize knowledge of six sigma, statistical analysis, and lean principles to investigate and solve problems and improve quality.
* Lead the creation and review of risk management files, including the risk management plan, product hazard analysis, FMEA's, risk management matrix, and benefit risk determination.
* Ensure risk management effectively integrates feedback from validation, field service, post-market surveillance, manufacturing indications, CAPAs, HRAs, etc.
* Familiarity with ISO 14971, risk management for medical devices, and IEC 62304 Medical Device Software.
* Understand and support all aspects of the QMS related to design controls.
* Develop and report status of quality and reliability metrics during phase reviews.
Qualifications and Skills
* Bachelor's degree or higher in a related field.
* 3+ years in a 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.