Our client, an Innovative and Expanding Medical Device Manufacturer here in Galway are looking Design Assurance Engineer to their team as they grow and expand into their next building.
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 in phoenix
- Understanding and complying with company quality, business, health & safety systems, and market/legal regulations.
- Removing or mitigating risks associated with the design, use, and manufacture of company devices.
- Acts as a reviewer for all design activities including design changes and assessment of all changes made by external manufacturers.
- Routinely provides design assurance guidance and direction to engineers and/or technicians.
- 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.
- Led risk management process and preparation of risk management files including the 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 with 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
- Required from time to time to :
- 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
- Customer Focus
- 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
- Risk Management
- Supports Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability, and Transportation testing.
- 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 Ph.D. (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 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 Mc Inerney.
091 706 717