A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re 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:
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
Software defect disposition
Product performance reviews
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.
Bachelor’s 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, FDA’s 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.