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Software Quality Assurance Engineer

2 months 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 position entails a variety of responsibilities that are crucial to our success.

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

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

FULL DESCRIPTION:

The chosen candidate will be tasked with:

  • Facilitating translation between Mandarin and English during meetings and general communications.
  • Translating documentation, including requirements, defects, and test protocols, from Chinese to English.
  • Effectively translating software and firmware terminology between both languages.
  • Conducting instrument testing while adhering to rigorous documentation standards.
  • Applying knowledge of FDA guidelines for documentation control and validation pertaining to medical devices.
  • Directly managing software through the FDA or IVDR processes, ensuring compliance with testing protocols.
  • Assigning test cases and defects to team members while balancing workloads efficiently.
  • Writing and refining requirements for both software and firmware, addressing any deficiencies.
  • Creating and updating test cases for software and firmware.
  • Reviewing test runs and protocols to identify defects or areas for improvement in software and firmware.
  • Assessing and addressing deficiencies in software and firmware testing and validation.
  • Documenting validation reports for software and firmware.
  • Managing a diverse team across various time zones.
  • Providing 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 prioritize software and firmware fixes.
  • Prioritizing tasks among assigned projects to ensure timely completion.
  • Familiarity with Smartsheet for project scheduling is advantageous.
  • Experience 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 different regions.
  • A comprehensive understanding of good laboratory practices.
  • The capability to manage multiple assignments efficiently.
  • A keen attention to detail.
  • Knowledge of medical instrumentation and laboratory techniques.
  • The ability to apply fundamental principles and theories to solve practical problems.
  • 5-10 years of experience in software/firmware validation or related engineering roles, preferably in the medical devices or in vitro diagnostics field.
  • Familiarity with FDA regulations related to medical device software and firmware validations, preferably in an ISO-certified environment.
  • Experience in a laboratory setting adhering to Good Laboratory Practices (GLP).
  • Understanding of software and firmware bug and defect tracking.

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