Senior Design Quality Engineer with strong working knowledge of Medical Device Instrumentation required for critical role with medical devices multinational in North Dublin. As a ‘Subject Matter Expert’, you will provide direction in the areas of design controls & risk management to cross-functional teams responsible for new product development & design changes to commercial products.
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
