Quality Engineer - Software
4255 Burton Dr. Santa Clara, California 95054 | Direct Hire
Position Title: Quality Engineer – Software
Position Description: Protingent Staffing has an exciting SW Quality Engineer opportunity within the Medical Device Industry in Santa Clara, CA.
- Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in a software development.
- Develop or specify standards to determine product or release readiness; Review test procedures, and assess changes to software for regression testing.
- Provide supporting in documenting software defects, using a bug tracking system, and report defects to software developers; Monitor bug resolution efforts and track successes.
- Ensure appropriate code syntax and correctness and able to understand software impact on overall system performance.
- Participate in product design reviews to provide input on functional requirements, product designs, schedules, or potential problems
- Support in conducting software compatibility tests with programs, hardware, operating systems, or network environments
- Support software approval process for release and other pertinent software documentation process for release
- Researches, develops, and designs test methods for programmable electronics, equipment, and systems of Ultrasound generators based on hardware and software requirements.
- Develops and assesses the quality programs and systems to applicable internal and external standards and regulations, and accepted engineering practices, such as IEC 60601-1, IEC 60601-1-2, and IEC 62304.
- Candidates must have Medical Device Quality Engineering experience and working knowledge of IEC 62304 for consideration.
- Candidates must have been a SW Quality Engineer within career.
- Must have 2-3 yrs. solid process compliance experience.
- Bachelor’ s Degree in Engineering, preferably Electrical Engineering, Computer Science, Systems Engineering, Biomedical or Mechanical Engineering.
- Work experience in Medical Device industry and quality.
- Good working knowledge of IEC 62304 and familiarity with IEC 60601 and applicable medical device standards.
- Medical device development knowledge, including V&V activities and direct V&V protocol development.
- Some light experience with supporting and performing code reviews (C++, C#, or Java), and understanding feasibility evidence, unit testing, test automation, software risk assessment.
- Experience working with Statistics.
- Knowledge of SW Build systems, electrical and electronic manufacturing processes as they apply to the design process.
- Hands on experience in dFMEA, pFMEA and risk analysis.
- Experience with embedded microprocessor controlled equipment development
- Experienced in iterative software design processes and development practices including agile and test-driven development
- Experience with requirements management, version control and bug tracking tools.
About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.