Job Description

Requisition ID

10045

- Posted

01/14/2026

Requirement 1: (2)

Job Title: Sr. Mechanical Engineer - Medical Devices

Location:

Pune, India

Experience:

7-12 years (Medical Domain Only)

Key Responsibilities

Effectively execute Engineering Design Activities for assigned NPD projects including conceptualization, modelling, Engineering analysis to final design and manufacturing drawings Lead the design and development of mechanical systems for medical devices, ensuring functionality, reliability, and manufacturability. Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to deliver innovative solutions. Completion of Design Outputs (Models, Rapid Prototypes, Drawings, Simulations, Technical Reports, Study Reports) Perform tolerance analysis, material selection, and stress analysis for critical components. Support process of completion of Prototype for V&V activities, support Validation Lab activity, documentation Ensure compliance with ISO 13485, FDA regulations, and other relevant medical standards. Drive design verification and validation activities, including prototyping and testing. Manage documentation for design history files and risk management per regulatory requirements. Mentor junior engineers and provide technical leadership in mechanical design.

Technical Knowledge/Functional Skills

Strong mechanical engineering fundamentals in design, materials, kinematics, mechanisms, stress analysis etc. Excellent understanding of mechanical design elements/features to achieve functional attributes.
Ability toknowledge to new designs. Competent modelling skills in CAD software (SolidWorks, CATIA V5) Competence in GD&T, ASME Y14.5 requirements, tolerance stack analysis Good understanding of FEA principles and techniques. Ability to formulate FEA study protocols, guide execution, analyse results, prepare reports. Good manufacturing process knowledge to enable DFM Excellent understanding of manufacturing processes and ability toknowledge to manufacture prototypes & support manufacturing in PD activities Excellent understanding of medical device materials, capabilities and limitations of materials, material selection for different device applications for both implants and instruments. (Preferred)

Understanding Standards such as ISO 13485, ISO 60601-1/2, ISO 14971 etc. (Preferred)

Good understanding of mechanical testing, ability to read/interpret test standards and relevant literature, formulate test protocols, design and manufacture test fixtures and rigs, set pass/fail criteria based on sound understanding of requirements, execute testing (IEC 61010).

Required Qualifications

Bachelor's/ Master's degree in Mechanical Engineering or related field. 10-12 years of experience exclusively in the medical device domain. Strong knowledge of biocompatible materials, precision machining, and injection moulding. Proficiency in CAD tools (SolidWorks, or equivalent). Experience with DFMEA, and risk analysis methodologies.

Requirement 2 (1)

Job Title:

Senior Engineer - Mechanical

Location:

Pune

Experience Required:

5-7 Years

Qualification:

Graduate or Postgraduate in Mechanical Engineering or related field

Primary responsibilities

:
Manage and support multiple projects ranging from

new product development to life cycle management/sustaining engineering

. Define

design requirements

and development specifications based on customer or user needs. Contribute to the development and documentation of

mechanical system

architectures. Participate in ideation, troubleshooting, and problem-solving for new product development and sustaining projects. Design

mechanical assemblies, mechanisms, and component parts

for electro-mechanical devices, ensuring compliance with requirements. Perform

mechanical analysis and calculations

, including kinematic analysis, tolerance analysis, and structural analysis (FEA) to evaluate design robustness and ensure safety of critical functions. Ensure successful integration of mechanical design elements with

electrical and consumable components.

Build and test

design concepts and engineering prototypes

for verification, compiling and presenting data to support design validation in accordance with company and regulatory standards. Participate in design reviews, evaluate design changes, and seek management approval for progression.

Qualifications and Skills:

Graduate or Postgraduate

in

Mechanical Engineering

or related discipline with

5-7 years

of relevant experience. Hands-on experience in

electromechanical product development

, preferably in medical devices. Proficiency in

CAD systems

for mechanical design and analysis (

CATIA & SolidWorks preferred).

Basic knowledge of standards such as

ASME, ANSI, ASTM

. Familiarity with GD&T, risk assessment, root cause analysis,

DFMEA, PFMEA.

Knowledge of

DFM & DFA

principles for ease of manufacturing and assembly. Expertise in design and manufacturing

metal and plastic parts.

* Strong communication skills (written and oral), including

technical documentation and presentation skills.