Senior Test Method Engineer
Job ID: JOB-12154
Senior Test Method Engineer
Our Medical Device Client in Galway are looking to attract a Senior Test Method Engineer to join their team on a permanent basis.
- 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 your 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.
- Undertakes and successfully completes complex test method development tasks including creation, writing, test method validation, equipment qualification and supporting on-going maintenance of test methods.
- Leads or participates in a cross functional team to translate product specifications into test methods.
- You will liaise 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 several staff in an assigned phase of a development project.
- You will provide technical expertise in test method development and validation supporting new development projects.
- You will liaise with other functions to ensure robust test method development meeting all stakeholders’ requirements.
- You will generate new test methods and test method related equipment and fixtures with all supporting materials.
- Lead and solve complex problems to resolution and solution implementation.
- As part of ongoing professional development, you will 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.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Develops, modifies, applies and maintains 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.
- Devises and implements 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.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
- May have practical knowledge of project management.
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
- You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
- Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.
For further information on this role in please contact Mark Wilson on 0860449473 or email firstname.lastname@example.org
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