Chief Software Quality Engineer

2 weeks ago

Dublin, Dublin City, Ireland beBeeDesign Full time €75,000 - €85,000
Job Overview

Software Design Assurance Professional Role

This is a unique opportunity to join our organization and contribute to the development, qualification, and commercialization of innovative medical devices and associated software.

Key Responsibilities:

  • Lead Software Quality initiatives for new product introductions and sustaining product development teams.
  • Collaborate with cross-functional teams on process optimization for efficient 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 comprehensive 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, standards, and internal procedures.
  • Provide detailed risk 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 to include the risk management plan, product hazard analysis, FMEA's, Risk Management Matrix, and Benefit Risk Determination.
  • Integrate risk management 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.
  • Develop and report status of Quality and Reliability metrics during phase reviews.

Qualifications and Skills:

  • Bachelor's degree or higher in a related field.
  • At least 3 years of experience 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.

Requirements:

  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work effectively in a team-oriented environment.
  • Self-motivated and proactive approach to meeting deadlines and objectives.

Benefits:

  • Opportunity to work on cutting-edge medical device technology.
  • Collaborative and dynamic work environment.
  • Ongoing training and professional development opportunities.

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