Design Assurance Engineer

Description

We are seeking a highly motivated and experienced Design Assurance Engineer to join an exciting opportunity working for a Medical device company in Galway. This individual will play a key role in supporting the life cycle of commercially released medical device products. The role involves managing design changes, ensuring continued compliance with risk management and design control requirements, and supporting complaint investigations to uphold the safety and effectiveness of devices.

Duties And Responsibilities:

• Support sustaining commercial projects from a Design Assurance perspective; direct involvement in making sure products are maintained through the full product life cycle and that these products comply with global standards.
• Lead and execute product/material design changes for commercially released products in accordance with regulatory and internal quality system requirements; experience and expertise in assessing for design, usability, sterilisation, biocompatibility and clinical impact.
• Provide DA technical direction/input to process changes for commercially released products in conjunction with R&D and Manufacturing Engineering.
• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
• Maintain and update the risk management file for post-market products, ensuring all identified risks are adequately documented and mitigated and assessing for product/material/process changes.
• Generation of Design Verification (DV) plans, protocols & reports and execution of DV testing to support product/material design changes and collection of shelf-life data to support regulatory submissions.
• Ensure continued design control compliance (per FDA 21 CFR 820.30 and ISO 13485), including design history file (DHF) maintenance, verification/validation planning, and traceability.
• Support complaint handling by participating in technical investigations, root cause analysis, and determining appropriate corrective and preventive actions (CAPA).
• Maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, and commercialisation activities.
• Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures. Generate and approve change requests.
• Assist in regulatory submissions and audits by providing documentation and subject matter expertise related to design assurance.
• Collaborate cross-functionally with engineering, manufacturing, regulatory affairs, and quality to implement and document product changes. Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
• Drive continuous improvement initiatives within the design assurance processes.
• Mentor junior engineers as needed.

Skills

• Medical device
• R&D
• Catheter
• New product development
• Risk analysis
• Design control
• Engineering
• Design assurance
• Validation
• Product development engineering
• Microsoft office
• Test method
• Fda
• Biocompatibility
• Mechanical engineering
• Risk management

Employee Value Proposition

Exposure to multiple departments and also manager is committed to developing candidates. Company is expected to drastically grow across next 3 years with new large expansion plans and also they have just received FDA approval as of June.

Job Title: Design Assurance Engineer

Location: Galway, Ireland

Job Type: Permanent

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.

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