Senior Design Assurance Engineer | Start Up, Galway, Collins Mcnicholas Recruitment

Senior Design Assurance Engineer | Start Up, Galway, Collins Mcnicholas Recruitment

Details + Details -

  • Job type: Full time
  • Contract type: Permanent
  • Salary type: Monthly
  • Occupation: Senior design assurance engineer | start up

Location + Location -

  • Country: Ireland
  • Region: Ireland
  • City: Galway

Description + Description -

This a fantastic opportunity for an experienced Senior Design Assurance Engineer to join an innovative and excitingstart-up here in Galway. The Role: 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. Responsibilities: 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. Requirements: 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 at 091 706 717

Search + Search -

Presented By: Collins Mcnicholas Recruitment