Job Title: Design Documentation & Validation – Senior Executive.

Department: Endoscopy and Women Healthcare

Location: Vapi, Gujarat

Reports To: Manager / Senior Manager – Endoscopy and Women Healthcare

Job Purpose:

To prepare, maintain, and manage design documentation throughout the medical device product development lifecycle, ensuring compliance with global regulatory requirements and quality management systems. The role involves Design History File (DHF) management, Design Verification & Validation (V&V), Risk Management, Technical Documentation, and regulatory submission support in accordance with ISO 13485, ISO 14971, MDR, FDA, CDSCO, and other applicable medical device standards.

Key Responsibilities:

1. Design Documentation & Design Control

• Prepare, review, and maintain Design History File (DHF), Device Master Record (DMR), Technical Documentation, and Design Control documents throughout the product lifecycle.
• Develop and maintain Design and Development Plans, User Requirements, Design Inputs, Design Outputs, Design Review records, and Design Change documentation.
• Prepare Engineering Change Orders (ECO), Engineering Change Notices (ECN), and maintain document revision history.
• Ensure complete traceability between design inputs, outputs, verification, validation, and risk management activities.
• Maintain document integrity in accordance with document control procedures and quality management systems.

2. Design Verification & Validation (V&V)

• Prepare Design Verification and Validation plans, protocols, reports, and summary documentation.
• Coordinate execution of verification and validation activities with R&D, Quality, and Testing teams.
• Develop and maintain Requirement Traceability Matrix (RTM) to demonstrate compliance with product requirements.
• Review test results and ensure documentation adequately supports regulatory requirements.
• Support design validation activities including usability, performance, functional, and reliability testing.

3. Risk Management

• Perform Risk Management activities in accordance with ISO 14971.
• Prepare Risk Management Plans, Hazard Analysis, Risk Analysis, Design FMEA (DFMEA), Process FMEA (PFMEA), and Risk Management Reports.
• Evaluate risk control measures and verify implementation effectiveness.
• Update risk documentation throughout the product development lifecycle.
• Ensure risk management activities remain aligned with design changes and product updates.

4. Regulatory Documentation & Compliance

• Support preparation of Technical Files, Design Dossiers, and regulatory documentation for CDSCO, CE Marking, FDA, and other global regulatory submissions.
• Ensure compliance with ISO 13485, ISO 14971, EU MDR, FDA Design Controls, and other applicable medical device regulations.
• Support regulatory gap assessments and documentation reviews.
• Assist during internal audits, external audits, customer audits, and regulatory inspections.
• Maintain documentation readiness for global regulatory submissions.

5. Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, Clinical, and Project Management teams.
• Support design transfer activities from development to manufacturing.
• Participate in design reviews and provide documentation support throughout the development process.
• Coordinate with testing laboratories and external consultants for documentation requirements.
• Support engineering change management and continuous improvement initiatives.

6. Documentation Management

• Maintain document templates, technical reports, specifications, protocols, and controlled records.
• Ensure timely preparation and approval of design documentation as per project milestones.
• Support electronic document management systems (EDMS/PLM/QMS) for document control and version management.
• Maintain documentation completeness and audit readiness throughout the product lifecycle.

Qualifications and Experience:

• B.E. / B.Tech / M.E. in Biomedical Engineering, Electronics, Mechanical Engineering, Medical Instrumentation, or equivalent.
• 6-8 years of experience in Design Assurance, Medical Device Documentation, Regulatory Documentation, or Product Development.
• Experience in medical device product development and regulated environments is preferred.
• Knowledge of global medical device regulatory requirements is highly desirable.

Skills and Competencies:

• Strong understanding of Design Controls and Design History File (DHF) management.
• Working knowledge of ISO 13485, ISO 14971, EU MDR, FDA 21 CFR Part 820, and CDSCO requirements.
• Experience in Design Verification & Validation (V&V) documentation.
• Proficiency in Risk Management methodologies including DFMEA, PFMEA, and Hazard Analysis.
• Excellent technical writing and documentation skills.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to manage multiple projects and documentation activities simultaneously.
• Effective communication and collaboration in cross-functional teams.
• Proficiency in Microsoft Office and document management systems (PLM/QMS/EDMS).

Key Performance Indicators (KPIs):

• Timely completion of Design History Files (DHF) and Technical Documentation.
• On-time preparation of Design Verification & Validation documentation.
• Accuracy and completeness of design documentation with minimal revisions.
• Successful support for regulatory submissions and audit readiness.
• Compliance with ISO 13485, ISO 14971, MDR, FDA, CDSCO, and internal quality procedures.
• Effective cross-functional coordination supporting project milestones and product development timelines.
• Timely closure of documentation-related observations arising from audits and design reviews.