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.
- Solid 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 :-

📌 Asst/Dy. Manager - R&D (Design & Development) (Faridabad)
🏢 Quality HR India
📍 Faridabad