1+ months

Senior Software Design Quality Engineer - Surgical Robotics

Medtronic
Boston, MA 02133
  • Jobs Rated
    8th
Senior Software Design Quality Engineer - Surgical Robotics

Location:

Boston, Massachusetts, United States

Requisition #:

18000OD5

Post Date:

Sep 10, 2019


**Careers that ChangeLives**


You
will join a team of mechanical, electrical and software engineers responsible
for developing Medtronics Robotic Assisted Surgery platform through commercial
launch and production scale-up.Impact
patient outcomes. **_Come for a job, stay for a career_** .


The
Minimally Invasive Therapies Group strives to enable earlier diagnosis, better
treatment, faster complication-free recovery, and enhanced patient outcomes
through less invasive surgical solutions.


SURGICAL
INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating
innovative surgical products and services that focus on obesity and diseases
and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic
region, and the head and neck.


**A Day in the Life**


Working
with collaborative team members, you will perform Quality Engineering functions
in support of projects associated with software development, requirement, design,
implementation, verification, and failure mode analysis.Work closely with RD and suppliers to
drive to quality improvements and conformance to standards and
regulations.


**You Will:**


+ Ensure the adequacy of software design quality for a Minimally Invasive Surgical System, including documentation and other supporting quality evidence

+ Drive Software FMEA across various subsystem within the Minimally Invasive Surgical System, as per ISO 14971, IEC80002-1

+ Facilitate cybersecurity activities including, but not limited to, planning, analysis, implementation, testing and post-market evaluation.

+ Participate in Engineering Design Reviews

+ Participate in Defect / Issue Management and Change Control Boards, as appropriate

+ Participate in requirement, design, and testing reviews

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

+ 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 QE functions and management

+ Work closely with software engineers

+ Train and mentor associate quality engineers

+ Lead Software tool validation and SOUP analysis


**Must Have:**


Bachelor
of Science Degree and a minimum of5 years'
experience.


**Nice to Have:**


+ BS degree in Engineering, Math, Computer Science, or Equivalent; MS degree in Engineering, Math, Computer Science preferred.

+ Minimum 5years relevant experience as a Software Engineer or Software Quality Engineer responsible for software development, testing and/or Software Quality Engineering in a regulated industry (FDA, ISO, etc.).

+ 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.

+ Previous software development experience is Desired.

+ 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.


**Work Environment**


Office
environment where the employee would be standing and sitting most of the day at
a desk or in a conference room for meetings.


Some
travel may be required.


**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 JobRequirements**


The
above statements are intended to describe the general nature and level of work
being performed by employees assigned to this position, but they are not an
exhaustive list of all the required responsibilities and skills of this
position.


The
physical demands described within the Day in the Life 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.


**EEO**


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.


This
employer participates in the federal E-Verify program to confirm the identity
and employment authorization of all newly hired employees. For further
information about the E-Verify program, please click here:
http://www.uscis.gov/e-verify/employees .
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

Jobs Rated Reports for Software Engineer

Posted: 2019-03-01 Expires: 2020-02-16

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Senior Software Design Quality Engineer - Surgical Robotics

Medtronic
Boston, MA 02133

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Software Engineer
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Overall Rating: 8/199
Median Salary: $100,690

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