KEY RESPONSIBILITIES

1. Designing and Development of Plastic parts, Sheet metal, Die-casting, and precision Machined parts.

2. Working in 3D models using Solid works and able to make and review 2D drawings.

3. Have strong knowledge on GD&T; tolerance Stack up analysis at sub-system / system level and coaching team and reviewing tolerance analysis and applying to drawings.

4. Developing of proto parts, building system, identifying and addressing the issues on priority basis

5. Defining protocols and conducting the necessary testing required to validate the safety and effectiveness of the design(s). Developing test plans, test protocols, and test reports for product integration testing.

6. Working collaboratively with external development Suppliers. Willing to work with Cross functions (Manufacturing, purchasing, Service, regulatory, marketing, etc.) to deliver the product to market.

7. Conducting technical design reviews and reviewing the part design and drawings with reporting manager and supplier and ensuring designs are manufacturable.

8. Reviewing injection mold tool design and reviewing die-casting tool design and guide team on the same

9.



Writing specifications for mechanical system and sub-system, FMEA and Reliability assessment, Risk assessment, ISO 13485, ISO 14971, ECN, DHF, DMR.

10. Working on Bio-compatibility standards like ISO 18562; ISO 10993, RoHS, cleaning, disinfecting and Autoclave, IEC60601-1, ISTA, and Biocompatibility.

11. Carrying out any other task as assigned by the Reporting Manager

MINIMUM QUALIFICATION

1. B.E. Mechanical

MINIMUM EXPERIENCE

1. 5-7 years in cutting-edge product development or similar role

2. Surgical invasive medical devices industry preferred

SKILLS / COMPETENCIES NEEDED

1. Expertise in mechanical design, manufacturing drawings, tolerance stack up, calculations

2. Conceptualize and create mechanical designs for New Products and/or Installed Base mechanical components & subsystems using Mechanical Engineering principles.

3. Understanding of Medical Devices Standards

4. Open-minded, initiative, constructive & positive thinking, persistent, results-oriented, and able to work under pressure in changing environments

5. Team player and self-starter, able to perform with minimal supervision

📌 Senior Mechanical Design Engineer (Mumbai)
🏢 Xcellance Medical Technologies
📍 Mumbai