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

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 new 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 management, and quality systems.

• Project & People Management

• Lead project planning, execution, and reporting, ensuring on-time and within-budget delivery.
• Allocate resources effectively across projects and act as the technical escalation point.
• Mentor and develop junior engineers, set technical standards, and build internal capabilities.

Required Skills:

• Proficiency in SolidWorks, AutoCAD, CREO software and CAM/CNC integration tools.
• Hands-on with CAE tools (e.g., Ansys, Abaqus) for design optimization.
• Strong understanding of GD&T, material science (Titanium, SS316L, PEEK), and biomechanics.
• Experience in Additive Manufacturing (3D Printing), Rapid Prototyping is preferred.
• Deep knowledge of ISO 13485, ISO 9001, MDR, FDA 21 CFR Part 820.
• Familiar with DHF, DMR, TF, risk management, and product filing documentation.
• Proven ability to lead cross-functional teams, manage multiple projects, and mentor junior talent.
• Strong decision-making, problem-solving, and stakeholder communication abilities.
• Excellent written and verbal communication for technical documentation and presentations.

Required Qualification