Senior Design Quality Engineer with strong working knowledge of Medical Device Instrumentation required for critical role with medical devices multinational in North Dublin

Requirements: 

  • Level 8 Degree in Engineering or related Science
  • Ideally with 5+ years + relevant experience supporting the development and/or sustaining engineering associated with Medical Device Instrumentation in a regulated environment with a core appreciation of Global Medical Device regulations and specifically the implementation and application of design controls
  • Leadership skills and ability to influence cross functional teams to drive work scope to compliant and successful completion
  • Self-starter, bias for action with ability to support projects through to completion
  • Good organization skills
  • Cross technology and cross discipline collaboration skills
  • Understanding of Electromechanical Engineering, Software Development and Diagnostic instrumentation technologies is preferred
  • Are willing to contribute to change and guide teams in design control practice
  • Ability to guide change at all levels
  • Have the ability to collate and analyze large amounts of data to aid decision making
  • Have excellent oral communications, business writing skills and presentation skills
  • Self-directing, goal oriented and able to prioritize workload in a dynamic environment
  • Team player who can build strong and influential relationships with internal stakeholders and external partners

Key Responsibilities:

  • Serves as Subject Matter Expert (SME) for the application of Design Controls, while supporting development and design change teams in accordance with regulatory expectations and company procedures
  • Supports deployment of Quality Engineering tools for the effective and efficient development, transfer, and maintenance of IVD Instrumentation and related system software throughout the product lifecycle
  • Provides guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations related to Design Controls, Risk Management, Quality Engineering (e.g., Quality System Regulation, EU IVDD / IVDR, ISO standards, etc.)
  • Ensures the comprehensive completion of risk management, Design Verification, Process Validation, and Design Validation activities for products and processes
  • Supports the development and validation of appropriate test methods for product and process performance
  • Ensures active and thorough investigation of quality issues and effective corrective and/or preventive action
  • Provide competent Supplier Quality audit support with respect to the implementation of all Design Controls elements

    
emer@emtechrecruitment.ie

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