Our Client, an Irish Medical Device Developer which is currently at a really exciting stage in the product life cycle, is looking for a Software Design Assurance Engineer to join their team.
The successful candidate will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing medical devices and associated software.
Responsibilities include but are not limited to: 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 such as Data Protection, Privacy, and Security Assessments etc.
Develop Test plans, and test cases based upon the product and component level requirements.
Understanding of all aspects of the QMS related to Design Controls.
Provide detailed assessments of impacts for design changes on commercialized products.
Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
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.
Bachelor's degree or higher in a related field.
3+ years in regulated work environment, 2 of which should be 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.
Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies.
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