Senior Design Assurance Engineer

Our Client, a leading medical device company in Galway are hiring a Senior Design Assurance Engineer.

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.

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.

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.

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.

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.