Principal Systems Evaluation Engineer

Innovation - Diversity - 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.           

 

Principal Systems Evaluation Engineer, AIS Systems Engineering

Arden Hills, MN

 

We are seeking a seasoned Principal Systems Evaluation Engineer to lead the end-to-end evaluation of complex medical systems, including active implantable devices. This role is pivotal in ensuring system integrity through rigorous validation, verification, and design analysis. You will provide technical leadership and collaborate with cross-functional teams to effectively analyze system requirements, user needs, system design and perform comprehensive testing.

 

Key Responsibilities will include:

 

• Analyze system requirements and user needs for testability, perform system interaction analysis, and coordinate system evaluation activities (i.e. validation, verification, DAT) based on system requirements, user needs and system design.
• Transform requirements into test protocols and automated test scripts for end-to-end evaluation.
• Perform design analysis and exploratory testing.
• Track System V&V efforts by creating and maintaining records using approved tracking management tools.
• 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.
• Conduct special studies on subjects to improve systems evaluation/engineering practices, improve system quality, subsystem partitioning, etc. by researching and identifying root cause.
• Provide leadership and continuously improve System V&V processes and work methodologies (using agile/lean principles to eliminate waste) by solving complex problems and interfacing with peers/cross-functional groups and analyze activities to improve workflow.
• Establish and promote a work environment that supports the Quality Policy and Quality System. Demonstrate primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Lead and coordinate work of other engineers including offshore team members and mentor other engineers in engineering activities/methodologies and domain knowledge.
• Act as Systems Evaluation representative on cross-functional deliverables.

• Participate in and support pre-clinical studies.

 

 

 

 

Required Minimum Qualifications:

 

• Bachelor’s degree in electrical engineering, Computer Engineering, Computer Science or related field
• 10+ years of overall work experience with 8+ years in engineering with product development, including experience with automated and manual testing. 

• Experience with requirements analysis, design, trade-off analysis, systems integration, risk management and V&V processes.

• Ability to interpret and research system requirements, system specifications, input/output processes.
• Proficient with Python and working knowledge of C++ or Java.
• Experience with configuration management, test management, requirements management, and issue tracking systems such as JIRA, AccuRev, Windchill etc.
• Willingness to work onsite at our Arden Hills location.

 

 

Preferred Qualifications:

 

• Experience in so