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Senior Test Method Engineer

Reference:KG-AQTN-038182
Location: Galway
Qualification:Degree
Experience:5-7 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Quality Engineer

Would you like to join a leading medical device company in Galway to further develop your career? This is an excellent opportunity for an experienced Test Method Engineering professional.

As The Senior Test Method Engineer, you focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. The department participates in the design process to ensure the performance and safety of the Class III devices they develop, and to assure this is maintained throughout the product lifecycle.

You will 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.

Responsibilities

  • 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 a number of 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.


Qualifications & Experience

  • We are looking for a qualified person to Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) and desirably with a minimum of 5 years relevant experience.
  • Experience with Solidworks or CAD Software, fixturing or model fabrication, anatomical knowledge, statistical knowledge.
  • You are a dynamic team player, can work effectively and proactively on cross-functional teams.
  • Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions.


If you are interested in this role, and meet the Qualifications & Experience listed above, please apply today!



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