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Sr Software Design Quality Engineer - REMOTE within the United States OR Northridge, CA

Los Angeles, CA 90006 Work Remotely
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Sr Software Design Quality Engineer - REMOTE within the United States OR Northridge, CA


Northridge, California, United States

Requisition #:


Post Date:

Nov 25, 2020

**Sr. Software Design Quality Engineer**

**Remote within the United States with the ability to travel to Northridge, CA on occasion OR Northridge, CA**

**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 teamas a subject matter expert by leading and providing technical design quality support for the new product development.In this role, the Senior Software Quality Engineer works as part of the quality team supporting the cross functional software development activities. Candidate possesses an understanding of software development process and medical device regulations. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

You will lead, direct, and organize Design Quality activities from design concept to design transfer. You will also serve as the Quality Core team member for various programs.

**About - Diabetes Business Group**

The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

Visit at to see an overview of the products in our Diabetes product portfolio.

**A Day in the Life**

+ As a Quality Core Team member, collaborate with cross-functional project team members as well as members of the QA extended team.

+ Demonstrate the ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.

+ Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.

+ Identify and implement process improvements to increase efficiencies and product quality.

+ Lead and drive collaborative design and development of medical devices.

+ Participate in the development of requirements, software design, interface and test design.

+ Collaborate develop SW FMEA to help drive good designs at early development stages.

+ Collaborate and develop system hazard analysis.

+ Ability to read software code and participate in detailed technical design and code reviews.

+ Lead and drive CAPA projects.

+ Collaborate effectively with the cross functional teams and other stakeholders.

+ Demonstrate excellent coding, design and test practices.

+ Understand the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).

+ Interact and form constructive working relationships with all levels of leadership within Quality, Marketing, RD, Systems Engineering and Operations.

+ Provide training and coaching to cross-functional peers in maintaining compliance to internal andexternal Quality requirements and regulations

+ Participate and support external regulatory audits and inspections.

+ Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

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**

+ 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.

+ Experience working in a regulated industry (e.g., FDA-regulated).

**Nice to Have (Preferred Qualifications)**

+ Masters Degree in Engineering, Quality, Regulatory, or related.

+ Working knowledge of embedded and mobile application development for medical devices.

+ Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.

+ Ability to author technical reports, business correspondence and standard operating procedures.

+ Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.

+ Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.

+ Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.

+ Self-Starter with a sharp focus on quality and customer experience

**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: 2020-11-03 Expires: 2021-02-05
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Sr Software Design Quality Engineer - REMOTE within the United States OR Northridge, CA

Los Angeles, CA 90006

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