Senior Software Quality Engineer
Must Have: Minimum Requirements
Bachelor’s Degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
Nice to Have: (Preferred Qualifications)
· Experience with software as a Medical Device or software as an accessory to a Medical Device
· Performance of risk analysis activities for a given clinical product
· Development of or previous oversight of manual or automated testing used in verification activities
· Experience working in an Agile Scrum Framework
· Strong understanding of the application of 21 CFR Part 11, 820 and FDA Guidances pertaining to the development and use of software as a medical device
· Strong understanding of the application of the ISO standards, 13485, 14971, 62304, 62366 and 60601
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.
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)
