Senior Design Assurance Manager – Galway | Collins McNicholas

Senior Design Assurance Manager – Galway

  • Reference: GJ43947
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing


  • Lead the Design Review process in compliance to internal procedures including EU and FDA requirements.
  • Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.
  • Work with product development to establish design specifications and product requirements
  • Ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements.
  • Lead risk management process and preparation of risk management files including Use and Design FMEAs as required.
  • In conjunction with the design teams identify product testing required and write design verification and validation plans, protocols and reports including specifically advising on sample sizing; including but not limited to Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing
  • Liaise with external vendors for product testing 
  • Preparation of Standard Checklists for all the applicable main harmonized standards
  • Generation and/or review of quality and technical documentation / change requests to support design activities.
  • Routinely provides design assurance guidance and direction to engineers and/or technicians.
  • Assist Regulatory with the compilation of design dossiers, technical files, essential requirements, and regulatory submissions documentation as required
  • Support various QA/RA activities including quality management, system reviews, internal & vendor audits, etc.
  • Assist QA/RA with the preparation of clinical trial documentation, manage product builds and records, review of protocols and reports, and manage clinical trial ethics committee’s approval.
  • Act as project leader on a clinical trial, managing all communications between affected parties.


Skills, Experience and Qualifications:

  • Minimum 5 years’ experience as Design Assurance Engineer or similar role in a medical device company.
  • Primary and/or a postgraduate degree BS, MS, or PhD (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).
  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
  • Working knowledge of the Medical Device Directive (93/42/EEC) and FDA requirements including Quality System Regulation (21 CFR 820), applicable harmonised standards and the ability to apply them in practice.
  • Knowledge and demonstrated practice of clinical trial methodologies as per EN ISO 14155.
  • Ideally have PTCA or PTA catheter Design or Quality Assurance experience
  • Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing an advantage.
  • Application of standard regulatory requirements
  • Change control management; design, process and system.
  • Communication, Presentation and meeting chairing
  • Customer Focus
  • Medical Device Industry and/or Profession Expertise
  • Problem Solving and Decision Making
  • Proficiency in Design & Development processes including planning and reporting test requirements for each phase of the process.
  • Quality of Work; maintains high standards despite pressing deadlines
  • Risk Management
  • Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing

For a confidential discussion and more information on the role/company please  email your CV


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Christopher O'Toole

Contact Consultant

  • Christopher O'Toole
  • Senior Recruitment Consultant
  • 091 706713
  • Connect with Christopher

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