Technical Writer (Medical devices) Intern

ConfidentialChennai, India

1 day ago

Job description

Technical Writer (Medical Devices) Intern —

Location : Chennai — IIT Madras Research Park (Onsite)

Employment : Contract (6 months) with option to extend or convert to full‑time

Start : Immediate

Stipend : 10,000 per month

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).

Generate / 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.

Must‑have qualifications

Passion for technical writing.

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, TOC / LOT / LOF, 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.

Skills Required

structured authoring, Iso 14971, Iso 13485, iec 62304 , Dita, Visual Communication

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Technical Writer • Chennai, India