Experience: 5–6 Years

Industry: Medical Devices / Healthcare & Lifesciences

Function: Product Development / Sustenance Engineering / Design Quality

Location: Bengaluru, India.

Employment Type: Full-Time

Role Overview

We are looking for an experienced Mechanical Engineer with 5–6 years of experience in the Medical Device industry, with strong expertise in Product Development, Design Controls, Product Sustenance, and Design History File (DHF) remediation.

The candidate will work with cross-functional engineering, quality, regulatory, manufacturing, and R&D; teams to support new product development as well as lifecycle management and remediation of existing medical devices in compliance with applicable quality and regulatory requirements.

Key Responsibilities

Product Development & Mechanical Design

- Support mechanical design and development activities for medical device products.
- Develop and review 3D CAD models, engineering drawings, specifications, BOMs, and design documentation.
- Participate in concept development, design reviews, prototyping, testing, and design verification activities.
- Support DFM/DFA activities and collaborate with manufacturing and suppliers.
- Perform engineering analysis, design evaluations, tolerance studies, and root-cause investigations.
- Support design changes throughout the product development lifecycle.

Design Controls

- Execute and maintain Design Control documentation in accordance with applicable medical device quality requirements.
- Prepare and maintain design inputs, design outputs, design reviews, verification and validation documentation.
- Support Design Verification (DV) and Design Validation (DV/Validation) activities.
- Develop and review engineering protocols, reports, test plans, and acceptance criteria.
- Ensure traceability between design inputs, outputs, verification/validation activities, and requirements.
- Support risk management activities and linkage with ISO 14971 requirements.

Product Sustenance / Lifecycle Management

- Provide engineering support for existing medical device products.
- Investigate product issues, manufacturing concerns,



field feedback, and design-related non-conformances.
- Conduct root cause analysis, impact assessments, and corrective actions.
- Support Engineering Change Orders/Requests (ECO/ECN/ECR) and product configuration changes.
- Evaluate component, material, supplier, manufacturing, and design changes for product impact.
- Support continuous improvement and product cost/quality optimization initiatives.

DHF Remediation

- Review and remediate Design History Files (DHF) for compliance with applicable quality and regulatory requirements.
- Conduct documentation gap assessments and identify missing, incomplete, or inconsistent design records.
- Establish traceability between design requirements, specifications, risk management, verification, and validation records.
- Review historical product development documentation and identify compliance gaps.
- Support preparation and remediation of engineering documentation in accordance with ISO 13485 and applicable regulatory expectations.
- Ensure appropriate document control, revision history, approvals, and traceability.

Quality & Regulatory Compliance

- Work in compliance with ISO 13485 and applicable medical device regulatory requirements.
- Support ISO 14971 Risk Management activities.
- Support CAPA, NCR, deviation, complaint investigation, and audit remediation activities where required.
- Participate in internal and external audits and provide engineering documentation/evidence.
- Ensure engineering deliverables follow established Quality Management System procedures.

Required Technical Skills

- 5–6 years of experience in Medical Device Product Development / Mechanical Engineering.
- Solid understanding of medical device design and development processes.




- Hands-on experience with Design Controls and DHF.
- Experience in Product Sustenance / Lifecycle Management.
- Good understanding of ISO 13485.
- Working knowledge of ISO 14971 and medical device risk management.
- Experience with engineering change management such as ECO/ECN/ECR.
- Experience with Design Verification and Validation documentation.
- Strong understanding of mechanical drawings, GD&T;, tolerance analysis, BOMs, and product specifications.
- Experience with 3D CAD tools such as SolidWorks, Creo, NX, or equivalent.
- Ability to perform technical documentation review and gap assessment.
- Strong problem-solving and root-cause analysis skills.

Preferred Experience

- Experience working with regulated medical devices such as surgical instruments, implants, diagnostic devices, capital equipment, or disposable medical devices.
- Experience in DHF remediation / design file remediation projects.
- Exposure to FDA 21 CFR Part 820 / QMSR, EU MDR, or other medical device regulatory frameworks.
- Experience with PLM/document management systems.
- Knowledge of manufacturing processes such as injection moulding, machining, sheet metal, extrusion, or assembly.
- Experience working with global cross-functional teams.

Soft Skills

- Strong analytical and problem-solving ability.
- Good technical writing and documentation skills.
- Ability to work independently with limited supervision.
- Strong communication and stakeholder management skills.
- Ability to work effectively with Engineering, Quality, Regulatory, Manufacturing, and R&D; teams.
- Strong attention to detail and compliance mindset.

Education Bachelor's / Master's Degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.

Key Competencies

- Medical Device Engineering | Product Development | Mechanical Design | Design Controls | DHF Remediation | Product Sustenance | ISO 13485 | ISO 14971 | Design Verification | Design Validation | Engineering Change Management | Risk Management | CAD | Root Cause Analysis | Technical Documentation

📌 Mechanical Engineer (Chennai)
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