Senior Design Assurance Engineer
Galway-based medical device company seeks a seasoned professional to fill the role of Senior Design Assurance Engineer.
Key Responsibilities:
* Design Assurance and Quality Control:
o Support comprehensive design verification and validation testing, ensuring robust test methods comply with regulatory standards.
o Lead or support Corrective and Preventive Actions (CAPA) initiatives related to design and test methods, driving continuous improvement.
o Oversee design controls and reviews, including participation in design reviews and design change processes.
o Conduct and manage Design Failure Mode and Effects Analysis (dFMEA), ensuring seamless transition to Process FMEA (pFMEA) during the design-to-manufacturing phase.
o Compile technical documentation for regulatory submissions, ensuring compliance with industry standards and regulatory requirements.
o Collaborate on human factors engineering and usability studies to optimize product safety and user experience.
* Testing and Validation:
o Develop and validate test methods to ensure product safety, effectiveness, and compliance with regulatory requirements.
o Create and maintain work instructions for testing and quality assurance processes.
o Evaluate process transition from design to manufacturing by transitioning design specifications to manufacturing specifications and design test methods to process test methods.
o Collaborate with external partners on design, manufacturing, and quality matters.
* Continuous Improvement and Problem Solving:
o Utilize structured problem-solving methodologies and conduct root cause investigations to resolve design and quality issues.
o Analyze design and test data using statistical tools and methods to inform decision-making.
o Support design optimization for manufacturability, ensuring cost-effective production without compromising quality.
* Cross-functional Collaboration and Communication:
o Communicate technical information and project updates to internal and external stakeholders effectively.
o Collaborate with R&D, Manufacturing, Quality Assurance, and Regulatory Affairs teams to ensure product quality and regulatory compliance.
o Maintain detailed technical documentation, including design history files, validation reports, and risk assessments.
Requirements:
* Bachelor's degree in Engineering, Scientific, or Technical field (ASQ Certified Quality Engineer (CQE) accepted).
* Minimum 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.
Desirable Skills:
* Experience with process or test equipment validation.
* Previous experience in a startup or SME environment, demonstrating adaptability and problem-solving in a dynamic setting.
* 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.