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Contact Info
Joan O'Malley
Life Science

0871897333
[email protected]
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Details

Senior Design Assurance Engineer


Reference:JOM AJNM-585301 Location: Galway City
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Assurance

Senior Design Assurance Engineer

Galway

  • Apply knowledge of design control and risk management principles and quality engineering techniques throughout the product development process
  • Contributes to Design Verification and Validation Strategies with functional partners (R & D and Regulatory Affairs) to assure an efficient regulatory submission approval path
  • Good working knowledge of test strategies for Biocompatibility, Sterilization, Shelf-life Protocols and Reports, Packaging Validation to applicable standards and ability to review and provide input to these areas of the product development process
  • Perform Gap Analysis as required of technical documentation for EU MDR 2017/745 and other projects as required
  • Understand and apply Risk Management concepts used to ensure Product Safety requirements in accordance with EN ISO 14971:2019+AMD11:2021 (ISO 14971:2019) and related guidance per ISO/TR 24971:2020
  • Generation of risk management file documents; Risk Management Plan, Hazard Analysis, Design FMEA, Process FMEA, Risk Management Report
  • Good working knowledge of test strategies for compliance to product related standards such as ISO 10555-1, ISO 11070 and ability to review and provide input to Design verification Protocols and Reports
  • Manage and maintain the records related to design control and risk management activities in accordance with QMS requirements at the client site
  • Ability to interpret polices, regulatory and/or governmental regulations, and internal regulations to assure compliance to design control, risk management and Quality Management System elements
  • Ability to apply systematic problem-solving methodologies in identifying, prioritizing, presenting, and resolving quality issues
  • Methodical review approach and is capable of initiating and leading change and continuous improvement
  • Proactive and stays abreast of industry best practices with respect to regulatory requirements for medical devices, knowledge of the application of EU MDR 2017/745
  • Perform all activities in compliance with client safety standards and SOPs
  • Participate in other projects/duties as assigned
  • Third level qualification in Engineering or Science. Minimum Bachelor’s Degree (Level 8) in a Science / Technology / Engineering related discipline. Masters (Level 9) in a related Engineering or Science discipline advantageous.
  • Minimum 5 years’ experience in a Medical Devices environment with proven track record of collaborating with others to design and develop high priority medical technologies and successful regulatory submissions approvals
  • Working knowledge of and experience with U.S FDA regulations, the Medical Devices Directive (93/42/EEC), EU MDR 2017/745, ISO 13485 Quality System Standard, ISO 14971 Risk Management, IEC 62366 Usability Engineering (Human Factors Engineering)
  • Knowledge of medical devices therapeutic areas (E.g., Coronary, Structural Heart, Vascular and Neurovascular).
Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required.


Contact Joan O’Malley at 087-1897333 for more details.