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Quality Engineer - Software

Santa Clara, California 95054 | Direct Hire

Post Date: 01/10/2018 Job ID: 17925 Industry: Software

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.

Job Requirements:
  • 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.

Job Qualifications:
  • 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.

Gazelle Medina

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