Chief Software Assurance Specialist

5 days ago

Dublin, Dublin City, Ireland beBeeSoftwareAssuranceEngineer Full time €80,000 - €100,000
Software Assurance Engineering Position

Our client is seeking a skilled Software Assurance Engineer to support the development, qualification, and commercialization of innovative medical devices and associated software. The successful candidate will work closely with colleagues to provide leadership in software quality, process optimization, and regulatory deliverables.

  • Provide strategic guidance on software quality for new product introductions and sustaining product development teams.
  • Collaborate with software development teams on process improvements for efficient iterative generation and maintenance of regulatory documents.
  • Support the creation and review of medical device software documentation, including design specifications, verification testing plans, and cyber security assessments.
  • Develop test plans and cases based on product and component level requirements.
  • Ensure that product development projects comply with applicable regulations, standards, and internal procedures.
  • Assess impacts of design changes on commercialized products.
  • Apply Six Sigma, statistical analysis, and lean principles to investigate and solve problems.
  • Lead risk management files, including risk management plans, hazard analyses, and FMEA's.

Requirements and Qualifications
  • 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 expertise 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.

Keyword: Software Assurance Engineer

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