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    • Tool Validation Engineer - Vilnius, Vilniaus - Softeq

    Softeq
    Softeq Vilnius, Vilniaus

    prieš 2 mėnesius

    Aprašymas

    Established in 1997, Softeq was built from the ground up to specialize in new product development and R&D, tackling the most difficult problems in the tech sphere. Now we've expanded to offer early-stage innovation and ideation plus digital transformation business consulting. Our superpower is to deliver all of this under one roof on a global scale. So let's get started and build a better future together

    Location and type of contract:

    Vilnius (Lithuania)
    - employment contract, hybrid work

    We build and operate Class-C medical devices where software tools (from CI/CD to test rigs and cloud services) directly influence product quality and patient safety. Your mission is to ensure these tools are
    fit for intended use
    ,
    risk-appropriately assured
    (CSA), and
    audit-ready
    at all times—without paper bloat.

    Responsibilities:

    • Own the tool inventory & classification:
      Maintain a complete, versioned register of development, test, manufacturing, and QMS tools; classify by
      intended use
      and
      risk
      (product impact, data integrity, patient safety).
    • Run risk assessments (CSA focus):
      Derive the
      right-sized assurance level
      per tool; choose scripted vs. exploratory testing, and when supplier evidence is sufficient.
    • Plan and execute validation:
      Author lean
      Validation Plans
      with measurable acceptance criteria, oracles/tolerances, datasets, and environments; produce
      assurance records
      that are repeatable and auditable.
    • Establish traceability:
      Link
      Requirement Criteria/Oracle Evidence Approval
      ; keep artifacts immutable and versioned
    • Control changes:
      Perform impact assessments for updates/patches; define targeted re-assurance (light regression vs. full) and prevent configuration drift.
    • Coach the org:
      Train teams on CSA principles (assurance over documentation), and good evidence; support test automation/HIL owners.
    • Measure what matters:
      Track coverage of validated tools, cycle time to approval, change SLA adherence, evidence quality, and audit outcomes.

    Requirements:

    • 5–8+
      years in regulated software, quality, or V&V; medical devices preferred (Class C exposure is ideal).
    • Regulatory fluency:
      Strong working knowledge of
      FDA CSA (Computer Software Assurance)
      ,
      ISO 13485
      ,
      ISO 14971
      ,
      IEC 62304
      ,
      21 CFR Part 11
      (eRecords/eSignatures) and
      ISO/IEC 27001
      is a plus.
    • Hands-on validation skill:
      You can design risk-based acceptance criteria and
      test oracles
      (spec/model/golden-master/property), and produce evidence that stands up in audits.
    • Change & config discipline:
      Experience with version control, release management
    • Tooling literacy:
      Comfortable with CI/CD, automated testing, scripting (e.g., Python), exposure to HIL/test rigs is welcome.
    • Communication & challenge:
      Clear, concise writing; confident in defending "right-sized" CSA against both over- and under-documentation.
    • Language:
      Excellent English (min. B2); German is a plus.

    Nice to have

    • Experience with
      test automation
      (system/HIL),
      GxP CSV
      , or
      AI/ML-assisted tools
      .
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