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1+ months

Sr Reliability Engineer

Boston, MA 02133
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Sr Reliability Engineer


Boston, Massachusetts, United States

Requisition #:


Post Date:

Dec 13, 2021

**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 Senior Software Design Quality Engineer working in the Seaport District of Boston, MA, you will use your expertise of software quality techniquesfor medical or other regulated systems. You will perform Quality Engineering functions in support of projects associated with software development, requirements testability analysis, verification, and failure mode analysis. Work closely with RD and suppliers to drive to quality improvements and conformance to standards and regulations.

**You will:**

+ Facilitate and manage Software FMEA across various subsystems within the Minimally Invasive Surgical System, as per ISO 14971, IEC 62304, IEC 80002-1.

+ Ensure the adequacy of software design quality for a Minimally Invasive Surgical System, including test design, protocol and results review and other supporting quality evidence.

+ Lead 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++).

+ Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative products.

+ Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.

+ Maintain appropriate communication channels with system level QA functions and management

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 4 years ofexperience, or advanced degree with a minimum of 2 years relevant experience

**Nice to have:**

+ Education Preferred: M.S. degree in Engineering, Math, Computer Science, or Equivalent.

+ B.S. degree in Engineering, Math, Computer Science, or Equivalent.

+ Minimum five (5) years of experience as a Software Engineer responsible for test and/or Quality Assurance (QA) in a regulated industry (FDA, ISO, etc.).

+ Previous software development experience is Desired.

+ Software failure mode analysis is desired.

+ Experience with JIRA, JAMA, MATLAB/Simulink preferred.

+ Knowledgeable with automated test tools

+ Managing experience is recommended.

+ 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.

+ Skills/Qualifications:

+ ASQ Certified Software Quality Engineer (CSQE)

+ Knowledge and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, 21 CFR 800, 13485, 62304, 14971, and 80002-1 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.


Posted: 2022-03-08 Expires: 2022-06-06
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Sr Reliability Engineer

Boston, MA 02133

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