Senior Systems Evaluation Engineer

Boston Scientific•Arden Hills, MN

3d•$85,000 - $161,500•Onsite

About The Position

The Senior Systems Evaluation Engineer is responsible for system-level evaluation of complex implantable medical device systems. This role analyzes system requirements and user needs and executes design verification and validation activities to ensure product safety, quality and performance. The engineer will support broader systems engineering initiatives by applying advanced engineering principles, methodologies and technologies to evaluate and improve product and system performance throughout the product development life cycle.

Requirements

Bachelor’s degree in Electrical Engineering, Computer Engineering, Computer Science or a related field with a minimum of 5 years' experience; or Master’s degree in Electrical Engineering, Computer Engineering, Computer Science or a related field with a minimum of 3 years' experience.
Strong analytical and problem-solving skills with the ability to collect, organize, synthesize and analyze data from multiple sources, develop conclusions and provide recommendations to stakeholders.
Ability to interpret system requirements and technical specifications, analyze test results and perform risk assessments.
Strong written, verbal and interpersonal communication skills.
Experience with Python, Perl, HTML, scripting languages or equivalent programming technologies.
Experience with change management, configuration management and issue-tracking tools such as JIRA, AccuRev, Windchill or similar platforms.
Experience developing automated test solutions and supporting test infrastructure.
Strong written, verbal and interpersonal communication skills with the ability to collaborate effectively across cross-functional teams.
Ability to manage multiple priorities in a regulated product development environment.

Nice To Haves

Minimum of 3 years' experience in software engineering, hardware engineering or a combination of both.
Minimum of 3 years' experience performing automated and manual testing within a regulated industry, preferably in the cardiac medical device industry.
Minimum of 2 years' experience working within a formal Systems Development Life Cycle (SDLC) environment.
Experience interpreting and applying regulations and standards applicable to Class II and Class III medical devices.
Experience creating test protocols and automating test execution using Python and related tools.
Familiarity with Cardiac Rhythm Management (CRM) systems and implantable medical device technologies.
Experience supporting verification and validation activities for complex medical device systems.

Responsibilities

Analyze system requirements, perform system interaction analyses and coordinate system evaluation activities, including verification and validation, based on system requirements and user needs.
Translate requirements into comprehensive test protocols and automated test scripts to support end-to-end system evaluation.
Perform design analyses, exploratory testing and root-cause investigations to identify and resolve product and system issues.
Identify root causes of issues and recommend effective corrective actions
Prepare final evaluation reports and partner with Regulatory Affairs to support compliance with applicable regulatory requirements.
Utilize version control, defect-tracking and peer-review tools, including AccuRev, JIRA and Windchill.
Create, maintain and track system verification and validation records using approved management and tracking tools.
Foster a work environment that supports the Boston Scientific Quality Policy and Quality System requirements.
Demonstrate a strong commitment to patient safety and product quality through adherence to all applicable quality processes and procedures.