Medical Devices JobsSenior Design Assurance Engineer

  • GY51566
  • Permanent
  • Galway

Collins McNicholas

A Medical Device SME is looking to hire an experienced Design Assurance Engineer on a permanent basis, in Galway. The ideal candidate will have 5 years+ working within this area in a Medical Device environment. 

Key Duties (full job spec available upon request)

  • Lead key elements of the Design Review process in compliance with 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 research and 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 
  • Lead key elements of the risk management process and preparation of risk management files including Hazard Analysis documents, Use FMEA, and Design FMEA.
  • Identify product testing required and write design verification and validation plans
  • Liaise with external vendors for product testing.
  • Preparation of Standard Checklists for all the applicable 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.
  • Supports regulatory compliance/submission process.

What you need to have 

  • 5+ years experience in a similar role
  • In-depth knowledge of the design control processes required for a Class III medical device
  • Possess a Degree in engineering, biomedical or science degree
  • Working knowledge of the Medical Device Directive (93/42/EEC)/Medical Device Regulation 2017/745 and FDA requirements including Quality System Regulation (21 CFR 820)
  • Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
  • Experience with involvement in Regulatory submissions would be an advantage.

For a confidential discussion and more information on the role, please contact Elaine Dolan.


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