Sr Software Quality Engineer Northridge CA or Remote within the US

Profile

**Sr Software Quality Engineer**
**21000AKO**
**Northridge, CA (Los Angeles) OR Remote within the US**
**Careers That Change Lives**
Medtronic Diabetes helps people gain better control and awareness over their diabetes. We work in the challenging space where medical devices are in the hands of everyday people, and those people expect state-of-the-art technology to help make managing their diabetes easier and more connected. Join the Medtronic Design Quality Assurance team as a subject matter expert driving quality into the design of new products.
In this role, the **Senior Software Quality Engineer** works as part of the core product team to collaboratively drive the software development activities for mobile applications, data driven insights and infrastructure services for digital solutions. The candidate must possess an understanding of software development life cycle processes (waterfall/agile/DevOps) as applied within the regulated medical device industry. You will work with the core R&D team to drive quality into product development and implement strategies that enable continuous improvement.
**Diabetes**
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. Were 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.
Visit ****to see an overview of the products in our Diabetes product portfolio.
**A Day in the Life**
- Engage as a quality core team member responsible for driving quality into the design and development of medical device applications.
- Lead the quality strategy for the design and development of software applications for medical devices adhering to compliance standards (such as ISO13485/IEC62304/HIPAA (FDA/Security Standards/Data Privacy).
- Drive the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D/Regulatory/Marketing/Operations.
- Drive compliance leveraging the Quality System using design control, risk management and change control processes.
- Drive quality focused design and development of software within the software development lifecycle (Agile/waterfall) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
- Lead the product risk management activities for the software applications leveraging SW FMEA and system hazard analysis tools.
- Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results. verification and validation reports.
- Drive review of complaints and resolution through the development life cycle.
- Lead and drive CAPA (Corrective and Preventative Action) projects.
- Participate and support external regulatory audits and inspections.
- Responsible for leading continuous process improvement projects to add, update or maintain software processes within the quality system adhering to compliance standards.
Responsibilities may also 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.
**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 4 years of work experience in Quality, Engineering and/or Software Development OR Advanced Degree in Engineering, Science or Technical field with 2 years of work experience in Quality, Engineering and/or Software Development.
**Nice to Have (Preferred Qualifications)**
- Masters Degree in Engineering, Quality, Regulatory, or related.
- Experience working in a regulated industry (e.g., FDA-regulated.
- Working knowledge of ISO 13485/ISO 14971/21 CFR 820/IEC 62304/IEC 60601-1/MDD/HIPAA/Cybersecurity/Digital Health
- Experience executing in a SDLC environment leveraging ALM tools (Eg: PTC Integrity/Atlassian Suite), defect tracking tools
(Eg: Jira), change control tools (Eg: Agile MAP), development tools (Git, SourceTree, Android Studio, GitLab), test tools (Flutter)
- Knowledge of embedded software, mobile application development [(Java (objective-C), and Kotlin (Swift)) or cloud infrastructure services (such as Amazon AWS/Microsoft Azure/IBM Watson).
- Working knowledge of data driven insight solutions leveraging machine learning/artificial intelligence (AI).
- Working knowledge of integrated digital health systems including consumer products such as Apple Inc./Android products.
- Ability to author technical reports, business correspondence and standard operating procedures.
- Ability to apply knowledge and work with external vendors.
- Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization
**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)
Up to 25% travel to Northridge, CA office if working remotely.
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
Marketing
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

Company info

Sign Up Now - MiamiCrossing.com