MECHANICAL ROLE

Required Qualification Bachelor in Mechanical Engineering

Job Description:

We are seeking a Mechanical Design Engineer to join our medical device development team.

The ideal candidate will have hands-on experience designing plastic injection molded parts, sheet metal components, and precision machined parts.

You will be responsible for end-to-end product design including concept development, 3D CAD modeling in SolidWorks, design validation through calculations and simulation, and collaboration with cross-functional teams for prototyping and production.

Specific Job Skills Required Demonstrated proficiency in the following areas:

• Lead concept generation and feasibility studies for new mechanical designs in line with product requirements and regulatory constraints.

• Develop detailed 3D CAD models, 2D manufacturing drawings, and BOMs using SolidWorks, applying GD&T and best practices for documentation.

• Perform design calculations to validate mechanical strength, fit/function, and performance under load, pressure, or thermal conditions.

• Conduct tolerance analysis and stack-up studies to ensure robustness and manufacturability of assemblies.

• Design for manufacturability (DFM), assembly (DFA), and cost optimization, particularly for plastic injection molded, sheet metal, and precision machined parts.

• Select and specify COTS (Commercial-Off-The-Shelf) components based on performance, regulatory, and lifecycle criteria.

• Collaborate closely with toolmakers, mold designers, and manufacturing vendors to ensure feasibility, tooling readiness, and part quality.

• Prepare and maintain all relevant Design History File (DHF) documentation including design inputs, outputs, V&V protocols, and reports.

• Contribute to risk management activities, including FMEA, hazard analysis, and traceability of risk controls.

• Support the development of test fixtures, oversee prototyping, and participate in design verification and validation testing.

• Participate in cross-functional design reviews, integrating feedback from regulatory, quality, manufacturing, and user experience teams.. Read and understand the provided Design Inputs and Design requirements with minimal supervision. General Skill Required

• Self-motivated and able to work independently with minimal supervision.

• Must be a good team player and able to adapt to the work environment. Must have good verbal and written communication and interpersonal skills with good working attitude.