- Reference: GJ43947
- Job Type: Permanent
- Location: Galway
- Category: Engineering, Technical & Manufacturing
- 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 Ethylene Oxide 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.
- Assist QA/RA with the preparation of clinical trial documentation, manage product builds and records, review of protocols and reports, and manage clinical trial ethics committee’s approval.
- Act as project leader on a clinical trial, managing all communications between affected parties.
Skills, Experience and Qualifications:
- 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.
- Knowledge and demonstrated practice of clinical trial methodologies as per EN ISO 14155.
- Ideally have PTCA or PTA catheter Design or Quality Assurance experience
- Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing an advantage.
- 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
- Design Verification including Ethylene Oxide sterilization, Biocompatibility, Stability and Transportation testing
For a confidential discussion and more information on the role/company please email your CV to:firstname.lastname@example.org
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