Software Quality Assurance Engineer

2 weeks ago


Garden Grove, California, United States TalentZök Full time

Software Validation Engineer - TalentZök

OVERVIEW

Are you seeking a rewarding career opportunity with a dynamic organization? This role encompasses the responsibilities outlined below.

We are currently looking for a Software Validation Engineer who possesses:

  • A minimum of 5 years of experience in software or firmware validation, ideally within the Medical Device or In Vitro Diagnostic (IVDR) sectors.
  • Familiarity with FDA regulations and guidelines.
  • A Bachelor's Degree in Computer Science or a related field.

FULL DESCRIPTION

The successful candidate will be tasked with:

  • Facilitating translation between Mandarin and English during meetings and other communications.
  • Translating documentation, including requirements, defects, and test protocols, from Chinese to English.
  • Effectively translating software and firmware terminology between both languages.
  • Conducting testing on instruments while adhering to rigorous documentation practices.
  • Understanding FDA documentation control and validation requirements for medical devices.
  • Having direct experience guiding software through FDA or IVDR processes, with a solid grasp of testing methodologies to achieve compliance.
  • Distributing test cases and defects among testers to ensure a balanced workload.
  • Drafting and refining requirements for both software and firmware, addressing any gaps.
  • Creating and revising test cases for software and firmware.
  • Reviewing test runs and protocols to identify defects or areas for improvement.
  • Assessing and addressing deficiencies in software and firmware testing and validation.
  • Compiling validation reports for software and firmware.
  • Managing a diverse team across various time zones effectively.
  • Developing project schedules based on available resources, complexity, and timelines.
  • Writing and editing Hazard Analysis, Software Description, and Software Project Plan documents.
  • Evaluating customer complaints to determine their validity and priority for software or firmware corrections.
  • Prioritizing tasks among assigned projects to ensure timely completion.
  • Having knowledge of Smartsheet for project scheduling is advantageous.
  • Familiarity with Helix for defect tracking, requirements, and test protocols is a plus.

The ideal candidate will also demonstrate:

  • A Bachelor's degree in Computer Science.
  • Strong oral and written communication skills in both English and Mandarin/Chinese.
  • The ability to collaborate effectively with other departments across the US, Europe, and China.
  • A comprehensive understanding of good laboratory practices.
  • The capability to manage multiple assignments efficiently.
  • A detail-oriented approach to work.
  • Knowledge of medical instrumentation, laboratory techniques, and equipment.
  • The ability to apply fundamental principles and theories to practical problem-solving.
  • 5-10 years of experience in software or firmware validation or related engineering roles, preferably in the medical devices or in vitro diagnostics field.
  • Familiarity with FDA regulations pertaining to medical device software and firmware validations, preferably in an ISO-certified environment.
  • Experience in a laboratory setting adhering to Good Laboratory Practices (GLP).
  • Knowledge of software and firmware bug and defect tracking methodologies.

Salary Range: $90k-$120k/yr



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