Senior Quality Engineer

6 days ago

Dublin, Dublin City, Ireland beBeesoftware Full time €90,000 - €120,000
Software Design Assurance Engineer Role

We are seeking a Software Design Assurance Engineer to join our team in Dublin. This role will be responsible for providing software quality leadership for new product introductions and sustaining product development teams.

About the Job

The successful candidate will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable medical devices and associated software. The ideal candidate will have experience with verification and validation (V&V) and expert knowledge of IEC 62304 (Software Development Life Cycle).

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.
  • Understanding of all aspects of the QMS related to Design Controls.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the applicable regulations and standards, and internal company procedures.
  • Provide detailed assessments of impacts for design changes on commercialized products.
  • Use knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
Qualifications and Skills

The ideal candidate will have:

  • A 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.
Why Work with Us

This is an exciting opportunity to join a growing team and contribute to the development of innovative medical devices. If you are passionate about software quality and have a background in regulated environments, we encourage you to apply.

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