Sr Design Quality Engineer
- Bachelor of Science Degree in Biomedical, Mechanical, Electrical, Software, or other related fields
- 4 years of experience in Medical Devices
Nice to have:
- A Master’s Degree in Biomedical, Mechanical, Electrical, Software, or other related engineering field and/or 2 years of experience in Medical Devices
- Applied understanding of industry standards and regulations including, but not limited to: ISO 13485, 21CFR820, European Medical Device Directives (MDD), European Medical Device Regulations (MDR), ISO 14971, IEC 60601 series, IEC 62366-1, IEC 62304.
- Experience with any of the following software suites: Matlab, Minitab, SAS
- Experience applying Risk Management tools (Hazard Analysis, Risk Analysis, FMEA’s, Fault Tree Analysis, Use Error Analysis, etc.)
- Experience applying root cause analysis tools (Fishbone charts, 5 Why’s, DMAIC, etc.)
- Experience writing or guiding product requirements development*
- Experience with gynecological medical devices
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.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)