Job Description:

Key Responsibilities

Design & Product Development
- Design and develop new products and improve existing products as per project requirements.
- Prepare and maintain technical documentation throughout all phases of research and development.
- Ensure all designs comply with applicable international codes, standards, statutory regulations, and safety requirements.
- Perform engineering calculations and analytical studies as per international standards.
- Evaluate manufacturing feasibility, assembly constraints, and cost optimization during product design.
- Apply Quality by Design principles during prototype development to achieve desired quality and reliability.
- Prepare Verification and Validation (V&V;) plans and documentation for current product development.
- Maintain and update Bills of Materials (BOM) and implement engineering changes accurately.

Project Management
- Assess project scope, timelines, and budgets to ensure successful project execution.
- Monitor project milestones and support timely completion of assigned projects.




- Work closely with the R&D; Manager to execute projects according to approved plans.
- Monitor team objectives and performance metrics to achieve departmental goals.

Compliance & Quality
- Ensure compliance with ISO 9001 quality management procedures.
- Understand and implement cGMP requirements applicable to pharmaceutical equipment.
- Maintain ISO documentation and participate in internal and external quality audits.
- Coordinate certification activities and approvals from regulatory/notified bodies including CE, ASME U-Stamp, and IBR.

Technical Coordination
- Coordinate with Production, Purchase, Quality, Sales, and other departments to resolve technical and design-related issues.
- Determine technical specifications for components and update ERP item codes when required.
- Provide technical support to Sales & Marketing for customer inquiries, equipment sizing, component selection, alternative solutions, and produc

📌 Design Engineer in a leading pharma machines manufacturing industry (Ahmedabad)
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📍 Ahmedabad