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19 days old

Software Quality Engineer

Medtronic
Louisville, CO 80027
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Software Quality Engineer

Location:

Louisville, Colorado, United States

Requisition #:

20000GLL

Post Date:

Nov 03, 2020


**Careers That Change Lives**


In this exciting role as a **Software Quality Engineer** you will have responsibility for ensuring the quality, reliability, and safety of software-based medical devices and Software as a Medical Device supporting our Cranial and Spinal Surgery business. This includes surgical robotics and surgical navigation systems.


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.


**Neuromodulation** delivers innovative therapies and solutions for neurological diseases, pain, and spasticity.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ 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.

+ Support new product development core teams to ensure the quality, safety, and reliability of software-based medical devices and Software as a Medical Device.

+ Lead the development of Software Quality Assurance plans.

+ Support the validation of non-product software used to develop, support, and validate Medtronic medical devices.

+ Promote continuous improvement through the use of tools and practices such as Agile, Scrum, Test-Driven Development, Lean, Six Sigma and Kaizen.

+ Serve as Quality Core Team Leader for software projects of low to moderate complexity.

+ Travel requirement less than 25%


**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 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.


**Nice to Have**


+ Hands-on experience with medical device software risk management, including software and use FMEAs.

+ Working knowledge of FDA Quality System Regulations and Guidances, Medical Device Directive, ISO 13485, ISO 14971, ISO 62366, and ISO 62304 standards.

+ Experience in a Regulated environment, preferably Medical Devices

+ Skilled in product risk assessment, requirements management and tracing, defect tracking, configuration management techniques, and how they are applied in the software development lifecycle.


**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.

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Posted: 2020-11-05 Expires: 2020-12-14
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Software Quality Engineer

Medtronic
Louisville, CO 80027

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