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Sr. Software Design Assurance Engineer - Northridge, United States - Medtronic
Description
Careers That Change Lives
The Senior Software Quality Engineer works as part of the core new product development team and sustaining to drive the software development activities for glucose sensing technology and automated insulin delivery systems to impact diabetics across the world.
In this role you will be a part of a fast-paced cross-functional team that works with latest generation of embedded solutions to maximize safety and minimize user burden.
DIABETES OPERATING UNIT (bookmark:
// MEDTRONIC OU_&) :
The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community.
As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it.
We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier.
Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.
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.A Day in the Life
Responsibilities may also include the following and other duties may be assigned.
Lead as a quality core/extended team member responsible for driving quality into the embedded software solutions in accordance with IEC 62304.
Lead quality focused design and development of software within the software development lifecycle (Agile/waterfall/ SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results.
Lead and conduct risk management activities including system risk analysis (ISO14971) and software FMEA's.
Lead and drive CAPA (Corrective and Preventative Action) projects.
Participate in both internal and external regulatory audits and inspections.
Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy)
Define appropriate metrics to measure product quality and drive reliability.
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.
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.
Must Have:
Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
Bachelor's Degree in Engineering, Science or Technical Field with 4+ years of experience in Engineering, Software Development and/or Quality
OR
Advanced Degree Engineering, Science or Technical Field with 2+ years of experience in Engineering, Software Development and/or Quality.
Nice to Have
Experience in software design, development, verification, validation and testing activitie for embedded software.
Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS,/MATLAB), defect tracking tools (Eg:Jira), development tools (Git), test tools (Eg: Selenium/JUnit), CI/CD tools (Jenkins).
Exposure with embedded C/C++ software.
Experience executing in the SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite/TFS), defect tracking tools (Eg:Jira), development tools (Git), test tools (Selenium/JUnit), CI/CD tools (Jenkins).
Ability to author technical reports, business correspondence and standard operating procedures.
Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
Exposure to medical device compliance standards (such as ISO13485/IEC62304/HIPAA/FDA/Security Standards/Data Privacy).
Certified scrum master or SAFe or Black Belt or Green Belt or CQE preferred.
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.
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.
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)A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits here ) .This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here .
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations).
Min Salary
94400
Max Salary
141600
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.
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