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Senior Design Assurance Engineer

  • On-site
    • Galway, Connaught, Ireland
  • Quality Assurance

Job description

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 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.


Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

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