Software Quality Engineer
Louisville, Colorado, United States
Sep 11, 2019
Software Quality Engineer
Careers That Change Lives
In this exciting role as a Software Quality Engineer you will witness cutting edge surgical navigation and robotic technologies designed to alleviate pain, restore health and extend life;Work closely with the new product development teams consisting of software, system, test and other software quality engineers in the development of new software releases for our product lines;Non-product software requirements definition and verification testing;Execute work using an Agile Scrum framework to manage development activities; andEngage in a collaborative, diversified and energetic team environment focused on delivering high quality products to our patients and users.Activities may include assistance with the following:
oFailure Mode and Effects Analysis
oVerification testing and reporting oversight
oSoftware defect disposition
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
BRAIN THERAPIES offers an integrated portfolio of devices
and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
A Day in the Life
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
Bachelor's Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Master's Degree Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.
Nice to Have (Preferred Qualifications)
- Experience with software as a Medical Device
- Understanding of 21 CFR Part 11, 820 and FDA Guidances pertaining to the development and use of software as a medical device
- Understanding of the ISO standards, 13485, 14971 and 62304
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)
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.