Boston Scientific Senior Systems Evaluation Engineer 

United States, Minnesota, Arden Hills 

361925479

About the role:

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.

Your responsibilities include:

• 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.

Minimum 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.
• 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.

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.