Senior Systems Engineer

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Purpose Statement:

Responsible for system level evaluation of complex implantable medical device systems by analyzing system requirements, user needs and perform system design verification and validation activities. Provide support for other System Evaluation and Design activities including current systems engineering principles and technologies.

 

Key Responsibilities:

• Analyzes system requirements, performs system interaction analysis, and coordinates system evaluation activities (i.e. validation, verification) based on system requirements and user needs.

• Transform requirements into test protocols and automated test scripts for end-to-end evaluation.

• Ability to perform design analysis and exploratory testing.

• 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.

• Utilize 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.

• Track 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.

 

The candidate must meet the following requirements:

• Bachelors (5+ year experience) or Masters (3+ year experience) in Electrical Engineering, Computer Engineering, Computer Science or related fields

• Ability to collect, organize, synthesize, and analyze data; summarize findings; develop conclusions and recommendations from all stakeholders using all sources of data.

• Ability to analyze test results and perform risk analysis.

• Ability to interpret and research system requirements, system specifications, input/output processes.

Required Technical Skills

• Experience in Perl, Python, HTML, scripting or equivalent.

• Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill etc.

Preferred requirements:

• 3+ year experience in software/hardware engineering.

• 3+ year experience automated and manual testing in regulated industry, preferably in cardiac medical device domain.

• 2+ year experience in system development lifecycle process including formalized processes and procedures.

• Ability to interpret and apply regulations and standards relevant to class II/III medical devices required.

• Create test protocols and automate tests using Python and other relevant tools.

 

 

Requisition ID: 580315

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. O