Job Boards Template

Search Jobs

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


Not ready to apply?

Send an email reminder to:

Share This Job:

Related Jobs: