Software Quality Engineer job in Sunnyvale, CA
Vacancy has expired
Sunnyvale, CA CorTech LLC
| Job Ref: | 342638 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 54.34/Per Hour |
| Remote: | No |
Location |
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| City: | Sunnyvale, CA |
| Post Code: | 94085 |
| Map: |
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Description |
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CorTech is seeking to hire a Software Quality Engineer for our client in Sunnyvale, CA! Benefits Available! Weekly Pay! $54.34/Hour Start Time (AM/PM) 9.00 AM End Time (AM/PM) 6.00 PM This is a non-exempt position. This position is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software utilized throughout the division. Duties: Develop and conduct training of company personnel for the divisional software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes. Create and execute or direct software validation protocols traceable to system/software requirements. Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems. Assist in the completion and maintenance of risk analysis, focused on software related risks. Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing). Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues. Software scoping and Part 11 audits. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. 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. Performs other related duties and responsibilities, on occasion, as assigned. BS degree in Engineering or Technical Field or equivalent experience. Qualifications: At least 7 years Software Quality Engineering experience. Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing skills. Advanced Information Technology and data mining skills. Prior medical device experience preferred. ASQ CSQE certification desired. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. 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. Ability to travel approximately 5-25%, including internationally. Ability to maintain regular and predictable attendance. 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. EDUCATION AND EXPERIENCE YOU?LL BRING Required 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 Preferred Experience with testing software within implantable medical devices is desired. | |
ref: (342638)
1086 days ago
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