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Job Title Location Salary  
Senior R&D Manager - Lifecycle Management Galway Not Disclosed
QA Engineer EU Not Disclosed
Product Development Engineer EU Not Disclosed
Senior Design Engineer EU Not Disclosed
Senior Equipment Design Engineer EU Not Disclosed
Senior Equipment Design Engineer EU Not Disclosed
Senior Device Design Engineer EU Not Disclosed
Validation & Verification Engineer EU Not Disclosed
Software Design Assurance Engineer Dublin Not Disclosed
Design Assurance Engineer Galway Not Disclosed
Validation and Verification Engineer EU Not Disclosed
Design Assurance Supervisor Mayo Not Disclosed
Senior Design Assurance Engineer Galway Not Disclosed
Senior Design Assurance Engineer Galway Not Disclosed

Design Assurance Career Profile

Design Assurance


Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.

Role/Responsibility

  • Support risk management activities
  • Evaluation of new products, assuring the safety and efficacy of the devices
  • Design verification and shelf life protocols / reports
  • Qualification and validation activities
  • Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
  • Adhere to Quality System and Design Control requirements
  • Root cause investigations; drive problem solving efforts for quality issues
  • Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
  • Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
  • Support customer complaint analysis and post market surveillance activities
  • Generate and approve change requests

Skill/Experience

  • Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
  • A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
  • A minimum of 1 years experience in product & process development

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