Test Method Validation Engineer
Design Assurance Engineer
My client is a Galway based medical Device manufacture with a new positions for a skilled Design Assurance Engineer. This role is commutable from Mayo & Roscommon, located outside of Galway City where they are headquartered however this role will facilitate full-time remote working.
In this role you will provide support the product development team and be responsible for supporting activities required to ensure development and validation of robust Test Methods. You will work closely with the whole Design Assurance team, product development engineering, clinical, marketing and regulatory to assure appropriate Test Methods are developed & Validated for the specific device application and target patient population.
What you’ll be doing in the role:
- Completes complex test method development tasks including: creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods.
- Leads cross functional team to translate product specifications into test methods.
- Work with extended team members to facilitate timely completion of Test Method Validation activities.
- Devise strategies for efficient execution of project deliverables and co-ordinate activities of a number of staff in an assigned phase of a development project.
- Provide technical expertise in test method development and validation supporting new development projects.
- Generate new test methods and test method related equipment and fixtures with all supporting materials.
- Maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities.
- Translates international standards and regulatory guidance into test methods.
- Develop, modify, applies and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Create and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or R&D as they apply to product or process quality.
- Bachelor’s degree in Engineering or another relevant technical discipline
- 4+ years relevant experience.
- Experience with Solidworks or CAD Software, model fabrication, anatomical knowledge and/or statistical knowledge highly preferred.
For further information on this Design Assurance Engineer role in Galway please contact Marchon Monroe on 086 0449473/ email@example.com
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