Staff Design Quality Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Galway, Ireland Job Description: We are searching for the best talent for a   Lead Design Quality Engineer . Purpose We are looking for a Lead Design Quality Engineer to join our MedTech Neurovascular team in Galway, Ireland. In this role, you will provide Design Quality technical and compliance expertise to support new product development, design changes, and lifecycle management activities. Working closely with Product Development, Regulatory Affairs, Manufacturing, and other multi-functional teams, you will help ensure products are developed and maintained in compliance with applicable regulations and company requirements. This role provides leadership in Design Control, Risk Management, and Quality System activities, supporting product development from concept through commercialization and post-launch activities. You will be responsible for In this role, you will lead Design Quality activities supporting new product development and lifecycle management programs. You will work closely with R&D and multi-functional partners to ensure Design Control and Risk Management requirements are applied effectively and consistently throughout product development and manufacturing processes. You will provide guidance on global medical device regulations and help teams interpret and apply Design Control and Risk Management requirements to support compliant product development and commercialization activities. Key responsibilities include: Leading Design Control and Risk Management activities to ensure compliance with applicable quality system requirements Partnering with R&D teams to support new product development and product lifecycle management activities Leading Design Quality activities associated with product launches and design transfer programs Guiding product development teams in the effective application of Design Control and Risk Management processes Supporting identification of design inputs, development of design outputs, failure mode prevention activities, and verification and validation strategies Supporting test method development, validation activities, competitive testing, process validation, design transfer, and launch planning Ensuring critical-to-quality requirements are identified and translated into design and process specifications Developing and maintaining risk management processes and risk control strategies to support product safety and performance Managing and delivering Quality-related requirements for R&D projects Providing Quality guidance and support to project teams and Design Quality Engineers Coordinating Design Quality resources, as needed, to support project and business priorities Applying structured problem-solving methodologies to investigate, prioritize, communicate, and resolve quality issues Maintaining Design Control records and supporting design review activities Reviewing and approving R&D batch documentation, production records, and sterilization records supporting Design Control activities Supporting bench testing activities, as required Monitoring