Design Quality Engineer (12 mth contract)

Job description

  Design Quality Engineer - Athlone (12 month contract)

Competitive salary & excellent benefits

TheDesignQuality Engineer position is one ofdevelopment, improvementand innovation, if you pride yourself on your problem solving skills, meticulous attention to detail andpassion for qualitythis may be the role for you.  You will be tasked to provide quality engineering support in design and development of medical device products,Airways, Breathing Circuits and Inhalation. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.  Help us shape the future

Desired profile

As our Design Quality engineer, your Key Accountabilities will involve :

·  Review new and modified product designs for quality characteristics, including     manufacturability, serviceability, testability, reliability, and product requirements.
·  Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.
·  Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report).
·  Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance.
·  Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Minimum requirements:

·  BSc Mechanical engineering or related discipline with 3 years’ experience in a similar role
·  Good verbal and written communication skills including protocol / report development and technical presentations.
·  Experience Risk Management ISO 14971
·  Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
·  Experience of verification/validation test plan development and root cause failure analysis.