Technical Writing Intern

0 years

0 Lacs

Posted:1 week ago| Platform: Linkedin logo

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Work Mode

Remote

Job Type

Full Time

Job Description

Technical Writer (Medical Devices) —

Location:

Employment:

Start:


Why this role

User/Operator Manual


What you’ll own (deliverables)
  • Operator Manual (IFU):

     setup, priming, alarms, operating modes, UI walkthroughs, cleaning/sterilization, warnings/contraindications, symbol glossary (ISO 15223‑1), and labeling content.
  • Service & Maintenance Manual:

     scheduled PM, test points, calibration procedures, fault codes, troubleshooting trees, disassembly/reassembly with torque specs, ESD and safety controls, spares & consumables lists, and exploded‑view diagrams.
  • Installation & Commissioning Guide (Site‑Ready):

     facilities requirements, power/EMC/grounding, acceptance checklists, and verification steps.
  • Field Bulletins & Work Instructions:

     change summaries (ECOs), retrofit kits, service advisories, and controlled WIs.
  • Verification/Validation Documentation Support:

     author/format protocols & reports (e.g., endurance, hemolysis, performance curves), acceptance criteria tables, and traceability to requirements.
  • Software Release Notes & UI Text Styleguide:

     error/alert taxonomy, revision history, and string conventions.
  • Training Collateral:

     quick‑start guide, competency checklists, and slide handouts.
  • Document Package Readiness:

     version control, approval routes, printable and web‑optimized PDFs, and source files (structured authoring).


Responsibilities
  • Plan a 

    documentation roadmap

     to reach DHF/DMR‑ready status; estimate effort, risks, and dependencies.
  • Interview engineers, clinical advisors, and service teams; convert tribal knowledge into clear, controlled content.
  • Create 

    procedures

     that are step‑by‑step, testable, and cross‑referenced with hazards, warnings, and PPE/ESD icons.
  • Build 

    troubleshooting flows

     for alarms/fault codes (symptom → probable cause → diagnostic steps → remedy).
  • Curate diagrams from CAD or photos; annotate assemblies and connectors; maintain consistent numbering schemes.
  • Ensure 

    regulatory alignment

     with ISO 13485 documentation controls, ISO 14971 risk controls/IFU warnings, IEC 60601‑1 & 60601‑1‑2 safety/EMC references, IEC 62304 software notes, IEC 62366 usability, and Indian CDSCO expectations.
  • Drive 

    reviews

     (RACI) and manage redlines; maintain change history, doc numbers, and revisions.
  • Prepare documents for 

    localization

    ; manage variables, units, and terminology consistency.


Qualifications
  • Good to have background in 

    medical‑device

     technical writing, including life‑support or OR/ICU capital equipment (HLM/CPB/ECMO/perfusion pumps, ventilators, monitors, etc.).
  • Proven authorship of an 

    IFU/User Manual

     and a 

    Service/Repair Manual

     that passed internal/external audits.
  • Working knowledge of 

    ISO 13485

    ISO 14971

    IEC 60601‑1/‑1‑2

    IEC 62304

    IEC 62366

    , and 

    ISO 15223‑1

    symbols.
  • Experience writing to 

    DHF/DMR

     standards with traceability to product requirements and risk controls.
  • Strong ability to read 

    schematics

    , wiring diagrams, and mechanical assemblies; comfortable with test instruments and fixture procedures.
  • Fluency in 

    structured authoring

     (DITA or equivalent) and 

    controlled docs

     (templates, numbering, revision control).
  • Excellent visual communication: creating 

    exploded views, callouts, and troubleshooting trees

    .
  • Superb written English suitable for clinicians and biomeds; clear, concise, and audit‑ready.



Application instructions

via linkdin


Compensation

INR 10,000 per month



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