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