Software Validation Manager

1 month ago

Garden Grove, United States Hycor Biomedical LLC Full time
THE ESSENTIAL FUNCTIONS OF THIS POSITION ARE AS FOLLOWS:

 

  • Provide translation from Mandarin to English and vice versa during meetings and other general communications.
  • Provide translation from Chinese to English for requirements, defects, test protocols and other general written communications.
  • Must be able to translate software and firmware terms between the two languages effectively.
  • Perform testing on the instrument using good documentation practices.
  • Knowledge of FDA guidelines for documentation control and validation for medical devices.
  • Direct experience mashalling software throught the FDA or IVDR, and who understands how to properly test software to meet those goals.
  • Assign test cases and defects to testers balancing the workload.
  • Write and edit requirements for both software and firmware and fill in deficiencies.
  • Write and edit test cases for both software and firmware.
  • Review test runs/protocols and identify defects or improvements for the software and firmware.
  • Evaluate and fill in deficiencies in the software and firmware testing/validation.
  • Write validation reports for software and firmware.
  • Able to manage a diverse team across various time zones.
  • Provide schedules for projects based on currently available resources, complexity, and timeline.
  • Knowledge of FDA guidelines for documentation control and validation for medical devices.
  • Write and edit Hazard Analysis, Software Description, and Software Project Plan documents.
  • Review customer complaints and determine validity and priority for software/firmware fixes.
  • Able to prioritize work among assigned projects and complete within schedule.
  • Knowledge of Smartsheet for project scheduling a plus.
  • Knowledge of Helix for defect tracking, requirements, and test protocols a plus.

Education:

Bachelor degree in computer science

Licenses/Certifications:

N/A

Skills/Abilities:

Strong oral and written communication skills in English and Mandarin/Chinese are required. Ability to interact well with other departments, here in the US, Europe, and in China. Detailed understanding of good laboratory procedures and practices. Ability to handle multiple assignments with efficiency. Must be detailed-oriented. Knowledge of medical instrumentation, laboratory techniques and equipment. Must be able to apply basic principles, theories and concepts to practical problem solving.

Experience:

5-10 years of software/firmware validation or other engineering experience, preferably in the medical devices or invitro diagnostics sector. Familiarity with FDA regulations as they relate to medical device, software/firmware validations, ISO-certified environment preferred.

Experience working in a laboratory environment following GLP.

Knowledge of software/firmware bug/defect tracking.

 

As a team member of Hycor, you will enjoy:

-Comprehensive benefit package, including health, vision, and dental insurance.

-401k

-PTO

*Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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