Senior Systems Evaluation Engineer
4 weeks ago
We are seeking a highly skilled Senior Systems Evaluation Engineer to join our team at Boston Scientific. As a key member of our engineering team, you will be responsible for evaluating complex implantable medical device systems, analyzing system requirements, and performing system design verification and validation activities.
About the Role:
In this role, you will analyze system requirements, perform system interaction analysis, and coordinate system evaluation activities based on system requirements and user needs. You will also transform requirements into test protocols and automated test scripts for end-to-end evaluation. Additionally, you will be responsible for design analysis and exploratory testing, working with electrical and mechanical hardware and associated tools and infrastructure.
Responsibilities:
* Analyze system requirements and perform system interaction analysis * Coordinate system evaluation activities 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 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 requirements and test assets * Track system 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
Requirements:
* Bachelor's (5+ year experience) or Master's (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
Why Boston Scientific?
At Boston Scientific, we are committed to advancing science for life and improving patient health. We recognize that nurturing a diverse and inclusive workplace helps us be more innovative and create a better, more rewarding place for our employees to work. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a workplace that reflects the patients, customers, and communities we serve. Boston Scientific is an equal opportunity employer and maintains a prohibited substance-free workplace.
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