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Medical Device Technical Documentation Intern

Medical Device Technical Documentation Intern

FLOAID MEDTECHChennai, Republic Of India, IN
7 hours ago
Job description

Technical Writer (Medical Devices) —

Location : Chennai — IIT Madras Research Park (Onsite, no WFH)

Employment : 6 Months with option to extend or convert to full‑time

Start : Immediate

Why this role

Floaid is finalizing documentation for a new platform. We need a hands‑on technical writer who can rapidly bring our User / Operator Manual , Service & Maintenance Manual , Installation & Commissioning Guide , and related controlled documents to release quality under a medical‑device QMS.

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 andconnectors;

    • 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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    Intern • Chennai, Republic Of India, IN

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