Works with stakeholders as appropriate to translate user needs into design requirements (e.g. hardware, software, mechanical, electrical, interface, etc.) consisting of system requirements, sub-system requirements, product/system security requirements, digital architecture, and system interface requirements to define the system as a whole and all associated sub-systems.
Analyzes system requirements, performs system interaction analysis, and coordinates system evaluation activities (i.e. validation, verification) based on system requirements and user needs.
Develops and maintains system-level software architectures and device workflows to guide medical device software and user interface requirements.
Transform requirements into test protocols and automated test scripts for end to end evaluation.
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.
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.
Bachelors (8+ year experience) or Masters (5+ year experience) in Electrical Engineering, Biomedical Engineering, Computer Engineering, Computer Science or related fields
5+ year experience in software/hardware engineering REQUIRED
5+ year experience automated and manual testing in cardiac medical device domain.
2+ year experience in system development lifecycle process including formalized processes and procedures.
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 required.
Experience with digital cloud-based architecture design and system interfaces.
Ability to interpret and apply regulations and standards relevant to class II/III medical devices required.
Ability to interpret and research system requirements, system specifications, input/output process and working parameter by using current systems engineering methods.