Our Client, a leading medical device company in Galway are hiring a Senior Design Assurance Engineer.Responsibilities include but are not limited to:Design Assurance and Quality ControlSupport Design Verification and Validation: Conduct and support comprehensive design verification and validation testing, ensuring test methods are robust and compliant with regulatory standards.Lead Corrective and Preventive Actions (CAPA): Drive continuous improvement by leading or supporting CAPA initiatives related to design and test methods.Design Controls and Reviews: Lead or support the design controls process, including participation in design reviews and design change processes.Risk Management: Conduct and manage Design Failure Mode and Effects Analysis (dFMEA) and ensure seamless transition to Process FMEA (pFMEA) during the design-to-manufacturing phase.Regulatory Compliance: Compile technical documentation for regulatory submissions, ensuring compliance with industry standards and regulatory requirements.Human Factors and Usability Studies: Support human factors engineering and usability studies to optimize product safety and user experience.Testing and ValidationTest Method Development: Develop and validate test methods to ensure product safety, effectiveness, and compliance with regulatory requirements.Work Instruction Development: Create and maintain work instructions for testing and quality assurance processes.Process Transition and Manufacturing Support: Ensure smooth transition from design to manufacturing by transitioning design specifications to manufacturing specifications and design test methods to process test methods.Collaboration with External Partners: Collaborate with external design, manufacturing partners, and suppliers to ensure product quality and compliance.Continuous Improvement and Problem SolvingProblem Solving and Root Cause Analysis: Utilize structured problem-solving methodologies and conduct root cause investigations to resolve design and quality issues.Statistical Analysis: Apply statistical tools and methods to analyze design and test data for informed decision-making.Design for Manufacturability (DFM): Support design optimization for manufacturability, ensuring cost-effective production without compromising quality.Cross-functional Collaboration and CommunicationStakeholder Communication: Effectively communicate technical information and project updates to internal and external stakeholders.Cross-functional Team Collaboration: Collaborate with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams to ensure product quality and regulatory compliance.Technical Documentation: Create and maintain detailed technical documentation, including design history files, validation reports, and risk assessments.Educational Background:Bachelor’s degree in Engineering, Scientific, or Technical field (ASQ Certified Quality Engineer (CQE) accepted).Professional Experience:Minimum of 3+ years of experience in Design Assurance or R&D within the medical device industry.Hands-on experience working within an ISO 13485 Quality Management System (QMS) or equivalent regulated environment.Strong experience with design controls, design reviews, and design change processes.Proficient in conducting Failure Mode and Effects Analysis (FMEA), particularly design FMEA.Demonstrated experience in problem-solving and root cause investigations.Technical SkillsProficiency in statistical tools and methods for design and quality data analysis.Strong working knowledge of MS Excel and MS Word for technical reporting and documentation.Familiarity with Quality Management Systems (QMS) and regulatory requirements, including ISO 13485.Communication and Collaboration SkillsExcellent verbal and written communication skills, with the ability to convey complex technical information clearly and concisely.Confident in engaging with internal teams and external partners, including design, manufacturing, and regulatory stakeholders.Experience Advantages – Preferred but Not RequiredExperience with process or test equipment validation.Previous experience in a startup or SME environment, demonstrating adaptability and problem-solving in a dynamic setting.Experience with Design for Manufacturability (DFM) to optimize product designs for efficient production.Background in validating test methods, test equipment, or test software.Strong background in the use of statistical methods for design and quality analysis.Experience with sterile devices, including design and validation for sterility assurance.Familiarity with electro-mechanical equipment or devices containing software, including usability testing and human factors engineering.Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.-Pale Blue Dot® Recruitment - The Resource for the MedTech Workforce-