Our client, a world leading medical device manufacturer based in Galway who are designing, developing and manufacturing their range of neurovascular devices are looking to hire a Design Assurance Engineer (HYBRID) as they embark on the expansion of their team and facility. The Design Assurance Engineer will be tasked with demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality. Understanding and complying with our clients quality, business, health & safety systems and market/legal regulations and removing or mitigating against risks associated with the design, use and manufacture of our clients devices.
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 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.
Proven success in the following job competencies:
Application of standard regulatory requirements
Change control management; design, process and system.
Communication, Presentation and meeting chairing
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
Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing
Skills, Qualifications & Experience
Minimum 3 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 on this position and a confidential discussion on the company please contact Chris O Toole