Manufacturing Engineer

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