Software Quality Assurance Engineer
2 weeks ago
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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