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

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 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: - B.E/B.Tech/M.E/M.Tech - Mechanical/Biomedical

Salary: - Upto 20.00 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-