Manufacturing Engineer

Yokoha Investment Pvt Ltd (Kalyani Group of company); Ranjangaon; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Yokoha Investment Pvt Ltd (Kalyani Group of company) is seeking engineers for Product Design & Development, Fixture Design and Process Drawing roles. You will design orthopedic implants and surgical instruments using SolidWorks, create detailed drawings, and support prototype testing and product commercialization.

The team collaborates with NPD, Manufacturing, Quality and Regulatory groups to ensure robust design, documentation and compliant manufacturability.

Qualifications

• Proficiency in SolidWorks with part, surface, and assembly modelling.
• Familiar with fixture design, BOM generation, and GD&T basics.
• Experience in engineering drawings and manufacturing process planning.
• Knowledge of design for manufacturing in medical devices is a plus.

Responsibilities

• Design and develop orthopaedic implants and surgical instruments using SolidWorks.
• Create 3D models, assemblies, manufacturing drawings, and design documentation.
• Develop concepts from customer, surgeon, and market requirements.
• Coordinate with NPD, Manufacturing, Quality, and Regulatory teams.
• Support fixture design, validation, and shopfloor implementation.
• Assist in process drawings, layouts, and change management activities.

Skills

SolidWorks

Part Modelling

Surface Modelling

Assembly Design

Drawing Creation

Fixture Design

BOM Generation

3-2-1 Locating Principle

Clamping Concepts

Work Holding Systems

Modular Fixtures

Inspection Fixtures

Engineering Drawings & GD&T

Manufacturing Process Planning

Job description

Product Design & Development

• Design and develop orthopaedic implants and surgical instruments for Knee, Hip, Shoulder, and Trauma applications using SolidWorks.
• Create 3D models, assemblies, manufacturing drawings, and design documentation.
• Develop product concepts based on customer, surgeon, and market requirements.
• Conduct design feasibility studies and design reviews.
• Support prototype development, testing, and product commercialization activities.
• Coordinate with NPD, Manufacturing, Quality, and Regulatory teams for successful product development.

Fixture Design & Manufacturing Engineering

• Design and develop machining fixtures, inspection fixtures, assembly fixtures, and work-holding solutions.
• Ensure fixture designs meet productivity, repeatability, and quality requirements.
• Work closely with CNC programmers and production teams to optimize machining processes.
• Select suitable clamping methods, locating principles, and fixture components.
• Support fixture validation, prove-out, and implementation on the shop floor.
• Modify and improve existing fixtures to reduce cycle time and improve operator ergonomics.

Process Drawing & Documentation

• Prepare detailed Process Drawings, Operation Drawings, and Manufacturing Layouts.
• Develop process flow charts, routing sheets, setup sheets, and work instructions.
• Create engineering drawings with GD&T requirements.
• Generate assembly drawings, exploded views, and inspection drawings.
• Maintain Bills of Materials (BOM), Design History Files (DHF), and Design Master Records (DMR).
• Manage Engineering Change Requests (ECR) and Engineering Change Orders (ECO).

Validation & Product Improvement

• Support design verification and validation activities.
• Perform tolerance stack-up analysis and fit-function evaluations.
• Participate in Design FMEA and Risk Management activities.

Manufacturing Support

• Support CNC machining process development and optimization.
• Assist in tooling selection and fixture standardization.
• Resolve design-related production and assembly issues.
• Support process validation activities including IQ, OQ, and PQ.

Quality & Compliance

• Ensure compliance with GMP, ISO 13485, and company quality procedures.
• Follow Good Documentation Practices (GDP).
• Support internal and external audits.
• Ensure traceability of design changes and product documentation.
• Participate in CAPA and continuous improvement initiatives.

Mandatory

• Strong proficiency in SolidWorks:
• Part Modelling
• Surface Modelling
• Assembly Design
• Drawing Creation
• Fixture Design
• BOM Generation

Knowledge Of

• Fixture Design Principles:
• 3-2-1 Locating Principle
• Clamping Concepts
• Work Holding Systems
• Modular Fixtures
• Inspection Fixtures
• Engineering Drawings & GD&T.

Manufacturing Process Planning