Job Description

 A SENIOR DESIGN ASSURANCE ENGINEER is required by CareerWise Recruitment for our multinational medical device client in Galway for a hybrid role on an initial 12-month contract.

The SENIOR DESIGN ASSURANCE ENGINEER will support sustaining commercial projects from a Design Assurance perspective and be directly involved in making sure the products are maintained through the full product lifecycle. This will also include the introduction/implementation of product/process/materials changes to the manufacturing operation.

THE ROLE:

• You will assess the patient risk appropriately for these design changes.
• You will provide QA technical direction/input to qualification and validation activities in conjunction with R&D and Mfg. Engineering.
• Responsible for generation of Design Verification protocols & will participate in the compilation of design verification and shelf life data for regulatory submissions to support design change approval.
• Interface with Regulatory Affairs to ensure information is clearly presented to minimize Regulatory Agency questions.
• Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment.
• You will generate and approve change requests.
• Lead investigation analysis and timely completion of same

REQUIREMENTS:

• Bachelors Degree (Level 8) in Engineering, Science, or related discipline.
• 4+ years’ experience in a design assurance/R&D/Quality role within the Medical Device industry
• Strong critical thinking and problem-solving ability
• Ability to collaborate effectively within a talented team and can work effectively and proactively on cross-functional teams.

Please call Laura Gallagher today for further information on 087- 4526468 or email: lgallagher@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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