1+ months

Sr Software Quality Engineer

Medtronic
Mounds View, MN 55112
Sr Software Quality Engineer

Location:

Mounds View, Minnesota, United States

Requisition #:

19000JXE

Post Date:

Oct 14, 2019


**Careers that Change Lives**


Under the
leadership of the Quality Core Team Member (QCTM), the Senior Software Quality/Reliability
Engineer provides SW quality engineering support to new product development
programs for Mechanical Circulatory Support (MCS) products. The purpose of this
role is to apply technical knowledge to complete SW product quality and reliability
assessments to ensure SW development for new products meets customer
performance expectations including IEC 62304 the requirements.


**CVG**


The Cardiac and Vascular Group brings all of our cardiac and
vascular businesses together into one cross-functional, collaborative operating
unit to employ the full breadth of our talent, technologies, products,
services, and solutions to address the needs of customers and patients across
the globe.


**CARDIAC RHYTHM AND HEART FAILURE** offers devices and therapies to treat
abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.


**A Day in the Life**


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


- Collaborating with project / program teams to ensure SW
development activities comply with Medtronic procedures and IEC 62304
requirements

- Working very closely with development teams during early development of
requirements design (algorithm development and code) and providing
feedback to the design based upon SFMEA/Hazard Analysis


- Lead SW Design for
Reliability (DfR) activities for applicable programs

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

- Understanding the interdependencies of program work products, guides 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) as required.

- Generating and driving risk management deliverables like SFMEA and Hazard
Analysis including facilitation / execution of the SFMEAs.

- Utilizes knowledge of various Software Development Lifecycles (SDLC).

- Driving clarity and consistency in documentation, supports evaluation of
software systems activities including requirements, design, development,
documentation, integration, test, verification and validation.

- Reviews verification and validation of software system requirements,
traceability, and testability to ensure adherence to design control policies
and procedures.


**Must Have: MinimumRequirements**


**Tobe considered for this role, please ensure the minimum requirements are evidenton your resume.**


+ Bachelors Degree in Engineering, Science or technical field with 4+years of work experience in Engineering and/or Quality OR Masters DegreeEngineering, Science or technical field with 2+ years of work experience inEngineering and/or Quality.


**Nice to Have**


- Masters Degree in Engineering, Quality, or related


- knowledge in Agile methodology

- 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

-Knowledge in cybersecurity evaluations and how potential threats may translate
to patient safety hazards

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

- High sense of accountability with a strong bias towards action in meeting assigned
program objectives


-Ability to multi-tasks, prioritize, meet/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)


Travel less than 10%
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: 2019-10-17 Expires: 2019-12-22

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Mounds View, MN 55112

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