Our client, a major multinational based here in Galway are looking for a Principal Reliability Engineer.
- Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
- Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path.
- Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Works independently to plan and schedule own activities necessary to meet timelines.
- 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.
- 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.
- Complete benefit-risk analyses to make risk-based decisions for product realization, from cradle to grave.
- Ability to lead or facilitate workshops for risk assessment (design, use, process etc) of a medical device using FMEA and/or other risk management tools.
- Engage with functions (R&D, PD, HFE) to identify and implement risk controls throughout the product development process.
- Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
- Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science), with 7+ years of experience in Engineering, Quality.
- A dynamic team player can work effectively and proactively on cross-functional teams with good communication and technical writing skills.
- Experienced professional in engineering development with extensive engineering knowledge and skills in some or all the following: risk management, sterilization of medical devices, test method development, design for six sigma principles, pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology, etc.), system requirements development, design control, application of ISO standards for medical devices.
For more information on this role and a confidential discussion please contact Michelle Mc Inerney on
091 706 717 or email firstname.lastname@example.org