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 recent 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 .
- Strong 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

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