Senior Mechanical Design Engineer

Xcellance Medical Technologies Pvt Ltd; Navi Mumbai; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Xcellance Medical Technologies Pvt Ltd in Navi Mumbai is seeking an experienced Mechanical Engineer to drive design and development of medical device components. You will model, analyze, and review parts for manufacturability, working with cross-functional teams to meet regulatory and safety standards.

The role emphasizes GD&T, tolerance analysis, and collaboration across manufacturing, purchasing, service, and regulatory functions to bring products to market.

Qualifications

• Strong experience in mechanical design for medical devices or similar products.
• Proficient in tolerance stack-up analysis at subsystem or system level.
• Solid understanding of GD&T and applying it to drawings.
• Proficient in 3D modeling using SolidWorks and creating 2D drawings.
• Ability to work with cross-functional teams including manufacturing, service, regulatory.

Responsibilities

• Design and develop plastic, sheet metal, die-casting, and precision machined parts.
• Create and review 3D models and 2D drawings in SolidWorks.
• Conduct GD&T tolerance stack-up analyses and coach the team.
• Develop proto parts, build systems, and address issues promptly.
• Define test protocols and perform validation for safety and effectiveness.
• Collaborate with external suppliers and cross-functional teams to deliver products.
• Perform design reviews and ensure manufacturability of parts and drawings.
• Review injection mold and die-casting tool designs and guide the team.
• Write specifications, FMEA, reliability, and risk assessments; maintain ISO docs.
• Adhere to biocompatibility standards (ISO 18562, ISO 10993, RoHS) and related testing.
• Carry out any other tasks assigned by the Reporting Manager.
• Ensure compliance with ISO 13485, ISO 14971, ECN, DHF, and DMR as applicable.

Skills

Mechanical design

Tolerance analysis

GD&T knowledge

SolidWorks modeling

Cross-functional teamwork

Education

B.E. Mechanical

Job description

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 innovative 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