Job Title: Documentation Engineer – Diagnostics
Department: Research & Development – Diagnostics
Location: Vapi, Gujarat
Reports To: R&D; Manager
Experience: 0–2 Years
Job Purpose:
To support the preparation, maintenance, review, and control of technical and engineering documentation for advanced in-vitro diagnostic (IVD) instruments, including automated Clinical Chemistry and Immunoassay Analyzers.
The role involves preparing and maintaining product development documents, design inputs and outputs, engineering specifications, test protocols, verification and validation reports, risk management records, SOPs, and product technical files. The engineer will collaborate with mechanical, electronics, embedded software, optics, fluidics, system engineering, and Quality teams to ensure accurate documentation, traceability, configuration management, and compliance with applicable medical device regulatory and quality requirements.
Key Responsibilities:
1. Technical Documentation & Engineering Records
- Prepare, review, and maintain technical documentation for diagnostic instrument development.
- Develop and maintain engineering documents, including product specifications, design descriptions, functional requirements, and technical reports.
- Prepare and maintain system architecture documents, subsystem specifications, interface documents, and engineering drawings documentation.
- Coordinate with engineering teams to collect technical inputs and convert them into structured technical documents.
- Maintain product development records, design review reports, meeting minutes, and engineering change documentation.
- Ensure accuracy, consistency, completeness, and traceability of technical information.
- Support preparation of technical manuals, installation guides, operation manuals, and service documentation.
2. Design Control & Product Development Documentation
- Support preparation and maintenance of Design History File (DHF) documentation.
- Maintain design inputs, design outputs, design review records, and design verification and validation documentation.
- Assist in preparing design plans, engineering specifications, requirement traceability matrices, and design review records.
- Maintain documentation related to mechanical, electrical, electronics, embedded software, optics, and fluidics subsystems.
- Support engineering teams in maintaining design change records and design transfer documentation.
- Ensure appropriate traceability between user requirements, system requirements, design specifications, and verification results.
- Support preparation and maintenance of product development documentation throughout the design and development lifecycle.
3. Verification, Validation & Testing Documentation
- Prepare and maintain test protocols, test cases, test procedures, and test reports.
- Support documentation of verification and validation activities for diagnostic instrument subsystems and complete systems.
- Coordinate with R&D; engineers to collect test results, observations, deviations, and corrective actions.
- Maintain records of functional testing, performance testing, reliability testing, and system integration testing.
- Support preparation of test reports for sample handling, reagent handling, fluidics, temperature control, optical systems, and instrument automation.
- Assist in maintaining requirement traceability matrices linking design requirements with verification and validation evidence.
- Ensure testing documentation is complete, accurate, approved, and properly maintained.
4. Quality Management & Regulatory Documentation
- Support documentation activities in accordance with applicable medical device quality management requirements.
- Assist in maintaining technical documentation aligned with ISO 13485 and applicable regulatory requirements.
- Support preparation and maintenance of Standard Operating Procedures (SOPs), work instructions, and quality records.
- Assist in maintaining documentation related to ISO 14971 risk management activities.
- Support preparation of risk analysis records, Failure Mode and Effects Analysis (FMEA), hazard analysis, and risk control documentation.
- Maintain document control records, revision history, approval records, and controlled document registers.
- Coordinate with Quality Assurance and Regulatory Affairs teams for document review, approval, and compliance activities.
- Support audit preparation and retrieval of relevant technical and quality records.
5. Document Control & Configuration Management
- Maintain controlled documents, document registers, revision histories, and approval workflows.
- Support document creation, review, approval, release, revision, and archival processes.
- Ensure documents are maintained using appropriate naming conventions, numbering systems, and revision control practices.
- Maintain records of engineering changes, document change requests, and change implementation status.
- Support configuration management of product specifications, engineering documents, software versions, and associated technical records.
- Maintain electronic and physical documentation repositories with appropriate access control.
- Ensure obsolete documents are identified and controlled to prevent unintended usage.
6. Cross-Functional Coordination & Product Integration
- Coordinate with mechanical, electronics, embedded software, optics, fluidics, and system engineering teams to collect technical information.
- Work closely with R&D; engineers to understand product architecture, subsystem functionality, and design requirements.
- Support documentation of integration activities involving mechanical assemblies, electronic controllers, sensors, actuators, fluidics, and optical systems.
- Participate in design reviews, technical discussions, testing activities, and project review meetings.
- Follow up with respective engineering teams for pending technical inputs, document reviews, and approvals.
- Ensure documentation accurately reflects the latest product design, engineering changes, and system configurations.
7. Innovation & Continuous Learning
- Contribute to the development and improvement of R&D; documentation processes and templates.
- Explore digital documentation systems, electronic document management systems (EDMS), and workflow automation.
- Support standardization of technical documentation across diagnostic instrument development projects.
- Identify opportunities to improve document traceability, accessibility, accuracy, and review efficiency.
- Continuously upgrade technical knowledge through mentoring, cross-functional collaboration, and exposure to medical device development processes.
Qualifications and Experience:
- B.E. / B.Tech. in Biomedical Engineering, Electronics Engineering, Mechanical Engineering, Instrumentation Engineering, Biotechnology, or a related discipline.
- Diploma in Mechanical / Electronics / Electrical / Biomedical Engineering may also be considered based on technical competency.
- Fresh graduates or candidates with up to 2 years of relevant technical documentation, engineering documentation, or quality documentation experience.
- Solid fundamentals in technical writing, engineering documentation, document control, and report preparation.
- Academic projects, internships, or practical exposure to engineering documentation, quality management systems, or medical device development will be preferred.
- Exposure to medical devices, biomedical instrumentation, laboratory automation, diagnostic equipment, or IVD products will be an added advantage.
Skills and Competencies:
- Strong technical writing, documentation, and report preparation skills.
- Good understanding of engineering documentation and product development lifecycle.
- Familiarity with Design History File (DHF), Design Inputs, Design Outputs, Design Verification, and Design Validation documentation.
- Basic understanding of ISO 13485, ISO 14971, and applicable medical device quality requirements.
- Familiarity with SOPs, work instructions, document control, revision management, and approval workflows.
- Understanding of verification and validation protocols, test cases, test reports, and requirement traceability matrices.
- Basic knowledge of FMEA, risk assessment, and design control documentation.
- Proficiency in MS Word, Excel, PowerPoint, and documentation management tools.
- Familiarity with PLM, ERP, QMS, or Electronic Document Management Systems (EDMS) will be an added advantage.
- Ability to understand engineering drawings, technical specifications, system architecture, and product development records.
- Strong attention to detail, organizational skills, and document accuracy.
- Good verbal and written communication skills.
- Ability to coordinate with multidisciplinary engineering and Quality teams.
Key Performance Indicators (KPIs):
- Accuracy, completeness, and quality of technical and engineering documentation.
- Timely preparation, review, release, and maintenance of assigned documents.
- Completeness and traceability of design control and product development records.
- Quality of verification, validation, and testing documentation.
- Effectiveness in maintaining document revision history and configuration records.
- Timely closure of document review comments and approval workflows.
- Compliance with applicable document control procedures and quality management requirements.
- Effectiveness in coordinating with cross-functional engineering and Quality teams.
- Audit readiness and retrieval efficiency of technical and quality documentation.
- Contribution to documentation standardization, process improvement, and R&D; documentation efficiency.
📌 Documentation Engineer – Diagnostics (Vapi)
🏢 Meril
📍 Vapi