Senior Test Method Engineer

CREGG are currently hiring a Senior Test Method Engineer to work onsite with a leading medical device multinational client in Galway. Call Stephen Coen 0861030418 Email: stephencoen@cregg.ie

Key Resonsibilities

• Be responsible for leading activities required to ensure development and validation of robust Test Methods.
• Work closely with your Design Assurance team, and cross-functionally with product development engineering, clinical, marketing and regulatory to translate product specifications into test methods and ensure appropriate test methods are developed & validated for the specific device, clinical use conditions and target patient population, meeting all stakeholders’ requirements.
• Undertake and successfully complete complex test method development tasks including replicating clinical use conditions, adhering to applicable standards, designing and sourcing fixtures, determining appropriate equipment and equipment qualification, programming test equipment and writing test scripts, and writing clear, concise setup and test procedure instructions.
• Undertake and successfully complete complex test method validation tasks including operator training, determining appropriate validation study design and sample size, data analysis including crossed gage R&R, ANOVA, Probability of Misclassification, identification and reduction of sources of variation and report writing.
• Liaise extended team members, test lab managers and test operators, to facilitate timely completion of test method development and validation activities in alignment with the overall project phase and project target milestones.
• Provide technical expertise in test method development and validation and support project investigations method development and validation activities in alignment with the overall project phase and project target milestones.
• 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.
• Translate international standards and regulatory guidance into test methods.
• Work independently to plan and schedule own activities necessary to meet timelines.
• Development of clinically relevant bench tests.

 Key Skills & Experience

 We are looking for a person qualified to Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science), with 3+ years of experience in Engineering, Quality.

• Experience in the management of complex data sets and statistical data analysis
• You are a dynamic team player, can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
• Collaborates and Creates Alignment, Thinks Critically and Makes Sound Decisions.
• May have practical knowledge of project management.
• Experience with Zwick (horizontal & Vertical), Micro VU, & HBLT, Particulate & Simulated use tesing.
• Experience with balloons and catheters ideal