Our Client, a leading medical device company in Galway, is hiring a Senior Design Assurance Engineer.
Responsibilities include but are not limited to:
Design Assurance and Quality Control
* Support 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 Validation
* Test 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 Solving
* Problem 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 Communication
* Stakeholder 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.
Job Requirements
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 Skills:
* Proficiency 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 Skills:
* Excellent 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 Required:
* Experience 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.
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