Must Have: Minimum Requirements:
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Bachelor’s degree required
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Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Nice to have:
- Education B.S. degree in Engineering, Math, Computer Science. Preferred: M.S. degree in Engineering, Math, Computer Science, or Equivalent.
- Minimum ten (10) years of experience as a Software Engineer responsible for test and/or Quality Assurance (QA) in a regulated industry (FDA, ISO, etc.).
- Previous software development experience is desired.
- Software failure mode analysis is desired.
- Experience with JIRA, JAMA, MATLAB/Simulink preferred.
- Knowledgeable with automated test tools
- Managing experience is recommended.
- Excellent communication skills, both written and oral and must be computer literate.
- Experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements.
- Skills/Qualifications:
- ASQ Certified Software Quality Engineer (CSQE)
- Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, 21 CFR 800, 13485, 62304, 14971, and 80002-1 requirements.
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Day in the Life 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.
EEO
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees