Careers that Change Lives
We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Design Quality Assurance and help shape policies that change lives. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Together, we can confront the challenges that will change the face of healthcare. Join us for a career that changes lives.
A Day in the Life
As a Design Quality Engineer, you will be taking an active part in the development of the company's products, by ensuring that design control is properly maintained and executed, you will monitor changes to current product designs, follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies
Responsibilities may include the following and other duties may be assigned.
- You will manage the risk management activities from the early stages of the development process and throughout the product lifecycle.
- You will review and approve product Verification and Validation strategy
- You will review and approve design documents and processes in accordance with Design Controls standards and company's policies.
- You will track product Standards to guide others on their correct implementation.
- Must Have: Minimum Requirements
- BSc Science/Engineering degree or higher
- At least 2 years prior experience related to design quality in a medical device company
- Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive MDD/MDR.
- Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis
- Working knowledge of software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards
- Demonstrated scientific analysis abilities
Nice to Have
6 sigma Certificate is an advantage
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.