Our client based here in Galway, through expansion are looking to hire a Design Assurance Engineer.
This role will be permanent offering a range of benefits.
- Fulfill the company’s design assurance responsibilities and related sustaining engineering activities, including:
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
- Understanding and complying to quality, business, health & safety systems and market/legal regulations.
- Removing or mitigating against risks associated with the design, use and manufacture of all company devices.
- Acts as reviewer for all design activities including design changes and assessment of all changes made by external manufacturers.
- 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.
- Give input to the Product design teams in identifying the product testing required and in the development of the Design Verification and Validation plans, protocols and reports including specifically advising on sample sizing (as an output of the dFMEA).
- Work with PD and reg to Prepare Standard Checklists for all the applicable main harmonized standards and ensure compliance to these standards
- Generation and/or review of quality and technical documentation / change requests to support design activities.
- Provides oversight on the development of new test methods
- Product Sterilization cycle development SME for Biocompatibility
- Support various QA/RA activities including quality management, system reviews, internal & vendor audits, etc.
- 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.
- Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing an advantage.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717