This a fantastic opportunity for an experienced Senior Design Assurance Engineer to join an innovative and exciting start-up here in Galway.
As the Senior Design Assurance engineer, you will be responsible for demonstrating and promoting a commitment to improving patient safety, customer satisfaction, and product quality as well as understanding and complying the company quality, business, health & safety systems, and market/legal regulations, hence removing or mitigating against risks associated with the design, use, and manufacture of the products.
- 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 the 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 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.
- Primary and/or a postgraduate degree BS, MS, or Ph.D. (Mechanical, Materials, Polymer, or Biomedical Engineering, or related technical field).
- More than 5 years of working experience in a quality role, preferably experience as Design Assurance Engineer or a similar role in a medical device company
- 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 harmonized standards, and the ability to apply them in practice.
- Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing is an advantage.
For more information or a confidential discussion about this role please contact Michelle McInerney
091 706 717