Design Quality Engineer with strong working knowledge of Medical Device Instrumentation required for critical role with medical devices multinational in North Dublin.
My client is expanding their engineering team to complement their existing broad-range of engineering competencies. You will be a key member of an expanding R&D team in developing and supporting next generation medical diagnostic analysers.
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.
Do you want to be part of a team designing life-saving medical devices?
- Level 8 Degree in Engineering or related Science
- Ideally with 3 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
- 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