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Job Details

Reliability Engineer I

Location
Boston, MA, United States

Posted on
Mar 01, 2022

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Profile

**Careers that Change Lives**
You will join a world class team of mechanical, electrical and software engineers responsible for further development and enhancement of the globally launched Medtronics Robotic Assisted Surgery platform through commercial launch and production scale-up: ******Impact patient outcomes. Come for a job, stay for a career**
In the Surgical Robotics (SR) business, part of Medtronics Medical Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to expand global access to care and reduce variability through robotic and analytics solutions.
**A Day in the Life**
As a Software Design Quality Engineer I working in the Seaport District of Boston, MA, you will use your expertise of software quality techniques for medical or other regulated systems. You will perform Quality Engineering functions in support of projects associated with software development, requirements & testability analysis, verification, failure mode analysis, and cybersecurity. Work closely with R&D to drive to quality improvements and conformance to standards and regulations.
**You will:**
Facilitate Software FMEA across within a scrum team as per ISO 14971, IEC 62304, & IEC 80002-1.
Ensure the adequacy of software design quality for SR including test design, protocol and results review and other supporting quality evidence.
Participate in Software tool validation and SOUP analysis
Drive cross functional cybersecurity analysis effort.
Participate in Defect / Issue Management and Change Control Boards, as appropriate
Participate in requirement review, verification test design.
Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control
Ensure all FDA and ISO verification & validation requirements are met and for the review and approval of all Software protocols (e.g. embedded, controls, C/C ).
**Must Have: Minimum Requirements**
Bachelors degree required
0 years of experience required
**Nice to Have**
Minimum 0-2 years of experience as a Software Engineer responsible for test and/or Quality Assurance (QA) in a regulated Previous software development experience is Desired.industry (FDA, ISO, etc.).
Software failure mode analysis is desired.
Experience with JIRA, JAMA, MATLAB/Simulink preferred.
Excellent communication skills, both written and oral and must be computer literate.
Experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO 14971, ISO 13485 requirements.
**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.
Categories
Healthcare
Engineering
Manufacturing / Production
Previous Job:
Prin Systems Engineer
Medtronic
Hyderabad, TS 500032 IN
Next Job:
Sales RepIIET@
Medtronic
Unspecified
Posted:
2022-03-01
Expires:
2022-03-31
Medtronic

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