Overview Job Title: Principal Reliability Engineer Location: Parkmore Galway Benefits: Bonus, Pension, Healthcare, Hybrid working (1 day from home)Job Purpose Cardiac Ablation Solutions (CAS) is an Operating Unit within the Cardiac portfolio with my client. At CAS, the team are developing next generation medical technologies that treat patients with abnormal heart rhythms. Our technologies save lives and improve the quality of living for millions of patients across the world by advancing innovation for the diagnosis and ablation of cardiac arrhythmias and enabling clinicians to perform procedures with superior outcomes. Our growing and innovative portfolio provides solutions that advance and enhance care. This position will be on-site (minimum 4 days per week) based out of Parkmore, Galway, Ireland site. Job Requirements Works closely with Research & Development in the development of Test methods to ensure that they are ready for the Test Method Validation (TMV) process. Ensures all TMV’s are validated to meet the required TMV procedure and standards. Takes direction from the quality core team member in delivering day to day project deliverables as an extended QCTM. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Perform systematic reliability analysis against features, requirements, architecture, interfaces, and designs, through the appropriate application of reliability engineering techniques (e.g. fault tree analysis, failure trending and analysis, reliability forecasting, etc.) to understand product and process robustness. Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements. You will lead strategies for test method validations, design verification and shelf-life protocols / reports. Education Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. Requires a minimum Level 8 Degree in Engineering or other relevant discipline and minimum 8 years of relevant experience. Or advanced Degree with a minimum of 7 years of relevant experience. May have practical knowledge of project management. Experience in a highly regulated industry, preferably medical devices. Experience with solving complex issues by interacting with cross functional groups. Proven ability to operate in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements. Knowledge of reliability tools and practices that effectively support requirements, design, integration and verification, and validation. Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact. Excellent communication and ability to influence is critical to the role. Does this sound like your next career move? To apply and for more info forward your application to the link provided or contact me on 087 0608656 OR colin.clare@lifescience.ie
