Boston Scientific Senior Systems Evaluation Engineer 

United States, Minnesota, Arden Hills 

179694752

Arden Hills, MN

As Senior Systems Evaluation Engineer, you will be responsible for system level evaluation of complex implantable medical device systems by analyzing system requirements and user needs. You will perform system design verification and validation activities. You will provide support for other System Evaluation and Design activities, including current systems engineering principles and technologies.

Key Responsibilities

• Analyze system requirements, perform system interaction analysis, and coordinate 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.
• Perform design analysis and exploratory testing.
• Work with electrical and mechanical hardware and associated tools and infrastructure.
• Write final evaluation reports and work with regulatory group to satisfy the requirements for external regulatory agencies.
• 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.
• Apply knowledge of XML, XSD, and XSL to manage the Requirements and Test assets.
• Track System Verification & Validation (V&V) efforts by creating and maintaining records using approved tracking management tools.
• Conduct special studies on subjects to improve systems evaluation/engineering practices, improve system quality, subsystem partitioning, etc. by researching and identifying root cause.
• Continuously improve System V&V processes and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow.
• Establish and promote a work environment that supports the Quality Policy and Quality System. Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Participate in and support pre-clinical studies.

Required Minimum Qualifications:

• Bachelor’s degree or more from an accredited school in Electrical Engineering, Computer Engineering, Computer Science or related field
• 5+ years of work experience in engineering with a Bachelor’s degree, including some experience with automated and manual testing or 3+ years of similar work experience with a related Master’s degree
• Experience collecting, organizing, synthesizing, and analyzing data; summarizing findings, and developing conclusions and recommendations from all stakeholders using all sources of data.
• Experience analyzing test results and performing risk analysis.
• Ability to interpret and research system requirements, system specifications, input/output processes.
• Experience in Python or C++.
• Experience with change management and issue tracking tools such as JIRA, AccuRev, Windchill etc.
• Knowledge of XML, XSD and XSL to manage the Requirements and Test assets.
• Willingness to work onsite at our Arden Hills location.

Preferred Qualifications:

• 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.
• Experience tracking System Verification & Validation (V&V) efforts by creating and maintaining records using approved tracking management tools.
• 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.

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.