Engineer, Software Quality - Senior or Lead
645 Almanor Ave Sunnyvale CA USA 94085 Sunnyvale, CA 94085 US
Perform specialized level software project activities in areas such as Development, Tools, Test, Requirements, and/or related areas for medical devices. Analyze requirements, plan, and schedule data, update and maintain different software specifications based on analysis of specifications, needs and improvements, and/or code based on strategic analysis. Exercise level appropriate technical judgement in planning, organizing, performing and/or coordinate engineer work. Work collaboratively to understand the clinical requirements of the software products and create test designs specific to those requirements. Create automated test designs and test scripts using python, to simulate clinical workflows related to cardiac arrhythmias by applying knowledge and understanding of medical device testing in Class II medical Devices such as ICD’s, Pacemakers. Conduct formal reviews of test designs and test scripts to comply with Quality Management Systems. Execute tests cases using various in-house and COTS tools.
WHAT YOU’LL DO
- Understand product requirements and use cases, and work on verification applications for Cardiac Rhythm Management (CRM) remote care in the areas including but not limited to - technical requirements development, identify test strategy, development of test design, test cases, test procedures and scripts, and test execution.
- Independently develop, debug and maintain automated test procedures
- Trains/mentors others on the teams
- Participates in and supports the implementation, development, enhancements, and modifications to software test scripts, and procedures
- Debugs, troubleshoots, and isolates software problems as well as offers strategic solutions, analysis, and advice regarding identified issues for future development
- Identifies parameters, structure, and critical test components
- Writes, updates, or executes test design, test cases, as well as test procedures (automated, semi-automated or manual) and analyzes and reports test results
- Contributes to and supports writing, updating, developing and maintaining Hazard/Risk/Cyber Security analysis specifications and cybersecurity testing
- Working from requirement specifications, develops, maintains, and updates test requirements and design/test protocols
- Presents at design reviews; documents and resolves issues
- Perform analysis and defect repair of one or more issues in the applications, as well as perform root cause analysis and identify corrective and preventive actions to address current and future issues.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Bachelors Degree in Software engineering, computer science, or a related engineering field, or an equivalent combination of education and work experience
- Minimum 6 years of progressively more responsible work experience in a range of software engineering disciplines using a variety of programming methods
- Experience with Python is required
- Experience with formal software development methodologies, and source code management is recommended
- Experience with unit- and integration-level testing and automated testing is recommended
- Experience with testing software within implantable medical devices is desired
- Ability to work in a highly matrixed and geographically diverse business environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Multitasks, prioritizes and meets deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Experience with testing software within implantable medical devices is desired.
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