Principal Software Quality Engineer

Profile

**Careers That Change Lives**
A career at Medtronic is like no other. Were purposeful. Were committed. And were driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. In this role you will witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life.
In this exciting role as a **Principal NPD Software Quality Engineer** you will have responsibility for providing Software Quality leadership to develop and release cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life.
**A Day in the Life**
Work closely with the new product development (NPD) teams consisting of software, system, test and other software quality engineers in the development of new software releases for our product lines. Act as the software quality lead for large and complex NPD projects, coordinating the work of other quality engineers in providing quality oversight and recommendations to improve the quality of the product design during the following activities:
NPD planning
Requirements definition
Software architecture and design
Risk analysis, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety
Verification and Validation testing and reporting
Human Factors Input and Validation testing and reporting
Automated testing
Software defect disposition
Product performance reviews
CAPA
DHF audits
NPD Management reviews
Provide quality oversight of non-product software requirements definition and verification testing.
Support internal/external regulatory inspection requests.
Mentor and provide leadership to other software quality engineers in their support of NPD projects.
Execute work using an Agile Scrum framework to manage development activities.
Engage in a collaborative, diversified and energetic team environment focused on delivering high quality products to our patients and users.
**Must Have: Minimum Requirements**
**To be considered for this role, please ensure the minimum requirements are evident on your resume.**
Bachelors Degree in Engineering, Science or technical field with 7 years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 5 years of work experience in Engineering and/or Quality.
**Nice to Have (Preferred Qualifications):**
Advanced Degree preferred.
ASQ Certified Software Quality Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (e.g. Six Sigma, Lean).
Versatility, flexibility, and a willingness to work within constantly changing priorities.
Work experience in quality assurance with a focus on software testing, and design control of software new product development.
Minimum 5 years experience in a quality role within the medical device, aerospace/defense or other highly regulated industry.
Working knowledge of IEC 62304, FDAs General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1 and MDD/MDR.
Expertise in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.
Strong working knowledge in one or more of the following areas: C/C , Linux/Unix, Python, automated testing frameworks.
Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
Excellent organizational, problem solving, and analytical skills.
Ability to manage priorities and workflow.
**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. Lets 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)
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.
Categories
Healthcare
Engineering
Financial Services
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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