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

- Solid 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

📌 Manufacturing Engineer (Pune)
🏢 Yokoha Investment(Kalyani Group of company
📍 Pune