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Medtronic Sr Software Quality Engineer - Surgical Robotics in Boston, Massachusetts

Sr Software Quality Engineer - Surgical Robotics

Location:

Boston, Massachusetts, United States

Requisition #:

2100004K

Post Date:

Jan 05, 2021

Careers that Change Lives

You will be a key member of Medtronics Minimally Invasive Therapies Group (MITG) Business Unit new productdevelopment teamworking to commercialize a Surgical Robotics Platform.

Impact patient outcomes. Come for a job, stay for a career. The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, fastercomplication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgicalproducts 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

As a Software Engineer, you will join a team of talented and driven engineers driving the development and commercialization of Medtronics next-generation Minimally Invasive Surgery (MIS) platform. You will have the unique opportunity to analyze the most exciting anomalies and critical cybersecurity vulnerabilities and build new software frameworksto mitigate these risks for theunderlying robotic platform. This is a great role that will enable you to gain a strong knowledge of different software components across the robotic system.

If you are a curious soul who is self-driven, loves to learn and believes in making a difference through innovation and creative problem solving in Healthcare, we would love to talk to you.

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

  • Participate in Software tool validation and SOUP analysis

Must Have: Minimum Requirements

  • Bachelors degree required

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

Nice to Have:

  • B.S. degree in Engineering, Math, Computer Science, or equivalent, advanced degree preferred.

  • Bachelors degree with a minimum of 6-8 years of experience, or advanced degree with 5-7 years of experience

  • Minimum 7 years of 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, 62304 requirements.

  • Previous software development experience is desired

  • Experience with robotics, controls, dynamics, kinematics, or motion control systems is strongly preferred

  • ASQ Certified Software Quality Engineer (CSQE)

  • Experience with Cybersecurity (EU and FDA)

  • Computer Science experience with UNIX/Linux / C++ / MATLAB.

  • Experience with one or more: SW Development, SW Testing

  • Understanding of functional and unit testing.

  • Understanding of risk-based analysis

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies andservices can do to help alleviate pain, restore health and extend life. We challenge ourselves and each otherto 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 withthe right people on our team. Lets work together to address universal healthcare needs and improve patientslives. Help us shape the future.

Working Conditions:

Work-from-Home and Standard Office setting in Boston, MA. Some limited travel may be required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employeesassigned to this position, but they are not an exhaustive list of all the required responsibilities and skillsof this position.The physical demands described within the Day in the Life section of this job description are representative ofthose that must be met by an employee to successfully perform the essential functions of this job. Reasonableaccommodations 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 regardto public assistance, veteran status, or any other characteristic protected by federal, state or local law. Inaddition, 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 authorizationof 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.

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