Asst/Dy. Manager - R&D Design & Development- Faridabad-Quality HR Services-8-15 - TimesJobs.com

Quality HR Services; Haryana; On-site; INR 15,00,000 - 20,00,000; Full time

Job summary

A leading Medical Devices company in India is seeking an Asst/Dy. Manager - R&D to lead design and development for advanced orthopaedic implants. The candidate should have expertise in SolidWorks, compliance with ISO standards, and the ability to lead cross-functional teams. This role demands strong communication skills and a background in Mechanical or Biomedical engineering, with a proposed salary of up to 20 LPA.

Qualifications

• Proficient in SolidWorks, AutoCAD, CREO software.
• Hands-on experience with CAE tools for design optimization.
• Strong understanding of GD&T and material science.
• Experience in Additive Manufacturing is preferred.
• Deep knowledge of ISO standards and regulatory frameworks.

Responsibilities

• Lead design and development of advanced orthopaedic implants.
• Collaborate across teams for seamless integration into production.
• Ensure adherence to regulatory frameworks and quality standards.
• Lead project planning and execution, mentoring junior engineers.

Skills

SolidWorks

AutoCAD

CREO

CAE tools (e.g., Ansys, Abaqus)

GD&T

Material science

Additive Manufacturing

Strong decision-making

Excellent communication

Education

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

Tools

CAM/CNC integration tools

Job description

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

Company Profile
It is one of the leading Medical Devices company and exporter in India.