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Senior Systems Engineer, CRM Systems Evaluation Job

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Date: Apr 3, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role: 

The person in this role is responsible for the development and evaluation of complex implantable medical device systems.  This is accomplished by writing and analyzing system requirements, user needs, and performing system design verification and validation activities. This role also provides support for other system design activities including current systems engineering principles and technologies.

 

Your responsibilities include:

  • Transforming requirements into test protocols and automated test scripts for end to end evaluation.
  • Ability to execute manual and automated test protocols.
  • Analyzes system requirements, performs system interaction analysis, and coordinates system evaluation activities (i.e. validation, verification) based on system requirements and user needs.
  • Ability to work with electrical and mechanical hardware and associated tools and infrastructure.
  • Able to write final evaluation reports and work with regulatory group to satisfy the requirements for external regulatory agencies.
  • Ability to develop and maintain high quality non-medical device software tools in a regulated environment to support system design and system evaluation functions.
  • Utilizes multiple version control, defect tracking, and peer review tools including Accurev, JIRA and Windchill.
  • Applies knowledge of XML, XSD and XSL to manage the Requirements and Test assets.
  • Tracks System V&V efforts by creating and maintaining records using approved tracking management tools.
  • Conducts special studies on subjects to improve systems evaluation/engineering practices, improve system quality, subsystem partitioning, etc. by researching and identifying root cause.
  • Continuously improves System V&V processes and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System. Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Ability to participate in and support pre-clinical studies.

 

What we’re looking for in you:

Basic qualifications:

  • Bachelors (5+ year experience) or Masters (3+ year experience) in Computer Science, Computer Engineering or Electronic Engineering, Systems Engineering (preferred)
  • 5+ year experience in software/hardware engineering.
  • 5+ year experience automated and manual testing in medical device domain.
  • 2+ year experience in system development lifecycle process including formalized processes and procedures.
  • Ability to collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations from all stakeholders using various sources of data.
  • Ability to interpret and apply regulations and standards relevant to class II/III medical devices required.
  • Experience/proficiency in MySQL, Perl, Python, HTML, scripting.
  • Experience with mobile device testing and automation tools Appium, Robotium, Geb/Spock, Selenium.
  • Experience working in Windows 10, Unix, QNX, Linux, IOS, Android operating systems.
  • Familiar with creating test protocols and automating tests using Python, VB, Perl and other relevant tools.

 

Preferred qualifications:

  • Experienced in XML/XSL/XSD (document schema as well as document querying and formatting using XSL) and XML processing using scripting languages.
  • Knowledge of XML infrastructure including XSL and XSD design
  • Experienced with C/C++ and JAVA object-oriented languages.
  • Familiarity with MATLAB.
  • Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill, DOCS etc.

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 473942


Nearest Major Market: Minneapolis

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