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Validation Engineer

Karwell Technologies

  • Boxborough, MA
  • 18 days ago
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    Skills

    • Best Practicesunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Debugging Skillsunmatched
    • Documentationunmatched
    • Functional Testingunmatched
    • Healthcareunmatched
    • LabVIEW Programming Languageunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Equipmentunmatched
    • Medical Equipmentunmatched
    • Mfg/PROunmatched
    • Process Validationunmatched
    • Product Supportunmatched
    • Product Testingunmatched
    • Regulationsunmatched
    • Test Automationunmatched
    • Test Plan/Scheduleunmatched
    • Testingunmatched
    • Validation Documentationunmatched
    • Validation Testingunmatched

    Description

    Roles & Responsibilities:
    • Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience.
    • Test Engineer that can help qualify Automated Functional Testers.
    • Would be responsible for writing all the documentation (requirement| trace matrix|. protocols| reports using the Healthcare templates) and executing the validations.
    • The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paperwork and qualify the systems.
    • Candidate may also help assemble the hardware side of the tester.
    • Good To have - Background in Test Stand | LabView that would be a bonus to help debug and trace requirements.
    • Qualify automated functional test systems and support troubleshooting.
    • Develop and maintain validation documentation| including requirements| trace matrices| test protocols| and reports.
    • Execute verification and validation testing| document results| and manage deviations.
    • Ensure compliance with internal quality systems and regulatory standards.
    • Collaborate with cross functional teams to support product testing and continuous improvement.
    Requirements:
    • Bachelors degree in Engineering or related discipline.
    • Experience in verification validation testing| preferably in medical devices or other regulated industries.
    • Familiarity with automated test systems and documentation best practices.
    • Strong analytical| documentation| and problem solving skills.
    • About Client Medical device customer USP of the Role and Project
    • Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using this.
    • The code for the testers will be written by an internal resources with whom this person would work closely in order to complete the paperwork and qualify the systems.
    • They may also help assemble the hardware side of the tester.
    • Candidate should have experience as tester development for Manufacturing
    • Candidate should have experience with the validations within the MFG environment - IQ| OQ| PQ.
    • Responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.
    • If they have background in Test Stand LabView that would be a bonus to help debug and trace requirements.
    • Essential Skills: Functional Testing.
    • Skills: Functional Testing.
    • Skills: MFG/PRO Domain (QAD).
    • Experience Required: 4-6.

    Numbers & Facts

    LocationBoxborough, MA

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