Design Quality Engineer

Job Description

Design Quality Engineer

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 66,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of; diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our Quality team now at Siemens Healthineers as a Design Quality Engineer. The role is based at our manufacturing site in Swords, Co Dublin, Ireland.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Design Quality Engineer you will:

·      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

·      As the SME, capable of providing competent Supplier Quality audit support with respect to the implementation of all Design Controls elements

·      This is an individual contributor role. The DQ Professional provides specialized direction to professional counterparts on teams.

·      This position is responsible to provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development, and Design Changes to commercial IVD hardware products. As a Subject Matter Expert (SME), the individual must be able to participate in Quality Management System improvement projects and Training efforts related to any of the elements within Design Controls.

This position may suit you best if would like to do develop your career with Siemens and you;

  • 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
  • Are Self-directing, goal oriented and able to prioritize workload in a dynamic environment
  • Are a team player who can build strong and influential relationships with internal stakeholders and external partners

Requirements to succeed in this role

  • Bachelor’s degree in Engineering or related Science discipline (QQI level 8).
  • Ideally with 3 years + relevant experience supporting the development and/or sustaining engineering associated with Medical Deice 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.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd

Experience Level: Experienced Professional

Job Type: Full-time

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