Job Description:

Position: Asst/Dy. Manager - R&D; (Design & Development)

Location: Faridabad

Experience: 8 - 15 Years

Industries: Pharma

Responsibilities:
- Product Innovation & Technical Leadership
- Lead design and development of advanced orthopaedic implants and instruments, focusing on innovation, clinical performance, and patient outcomes.
- Identify clinical needs and market trends, and translate them into product requirements through interaction with surgeons and marketing teams.
- Provide technical leadership for concept development, design feasibility, and prototyping.
- Design Execution & Validation
- Develop 3D solid/surface models, detailed technical drawings, and design documentation using SolidWorks, AutoCAD, CREO software and CAM tools.
- Conduct and review FEA(Finite Element Analysis )/CAE (Computer-Aided Engineering) analyses, biomechanical studies, tolerance stack-ups, and design risk analyses.
- Guide the team on design controls, DHF, V&V; activities, and risk management.
- Cross-Functional Collaboration
- Collaborate with Manufacturing, Quality,



Regulatory Affairs, and Supply Chain teams for seamless integration of design into production.
- Guide instrument design, tooling, fixture development, and DFM/DFA reviews.
- Participate in supplier evaluations, material selection, and troubleshooting during process scale-up.
- Process Development & Sustenance
- Lead initiatives on recent process validations (IQ/OQ/PQ), process documentation, and optimization.
- Drive sustenance engineering for legacy products – cost reduction, compliance upgrades, and lifecycle management.
- Ensure operational excellence through continuous improvement and feedback integration.
- Design Quality & Regulatory Compliance
- Ensure adherence to ISO 13485, ISO 9001, MDR, and US FDA regulatory frameworks.
- Own and review design documentation including DHF, DMR, TF, and regulatory submission support.
- Mentor junior engineers on best practices in documentation, change managemen

📌 Asst/Dy. Manager (Faridabad)
🏢 Quality HR India
📍 Faridabad