Job Description

Role: Mechanical Engineer
Experience: 5+ Years
Location: Bengaluru
Key Responsibilities:
Design & Development

• Lead end-to-end mechanical design of electro mechanical medical device components

and sub-assemblies from concept through production release.

• Develop detailed 3D CAD models and 2D drawings using SolidWorks, including

complex surface modelling for ergonomic and aesthetic design features.

• Apply Geometric Dimensioning & Tolerancing (GD&T) principles to ensure design

intent, fit, and manufacturability.

• Perform tolerance analysis and mechanical calculations to validate design robustness.
• Select materials and manufacturing processes (injection moulding, machining, casting,

sheet metal, etc.) suitable for medical applications.

• Support engineering builds and hands-on mechanical testing to evaluate design

functionality, performance, and reliability.

• Participate in design brainstorming, feasibility studies, and FMEA sessions to identify

and mitigate risks early in the design cycle.

• Collaborate closely with suppliers, toolmakers, and contract manufacturers to ensure

design feasibility, cost-effectiveness, and manufacturability.

• Review supplier drawings, tooling concepts, and first article inspection (FAI) reports.
• Drive Design for Manufacturability (DFM) and Design for Assembly (DFA)

improvements throughout the development process.

• Generate and maintain engineering documentation, including BOMs, drawings, ECOs,

and test reports, in compliance with ISO 13485 and FDA 21 CFR Part 820 design
control requirements.
Cross-functional Collaboration

• Work closely with electrical, software, and systems engineers to ensure seamless

mechanical integration.

• Coordinate with quality, regulatory, and manufacturing engineering teams

throughout the product lifecycle.

• Mentor junior engineers and contribute to best practices in design methodologies

and documentation.
Experience:

• 8-10 years of hands-on experience in mechanical design for medical devices
• Successfully worked as design engineer and was involved in the design of at least

one medical device during entire cycle of concept to production

• Expert-level proficiency in SolidWorks is a must, including surface and solid

modelling of complex geometries.

• Strong understanding and practical application of GD&T (ASME Y14.5) and tolerance

stack-up analysis.

• Expert-level proficiency in Design for Manufacturability (DFM) and Design for

Assembly (DFA) is a must

• Experience in plastic injection moulding, die casting, machined components, and

sheet metal design.

• Hands-on experience in prototype testing, fixture development, and test data

analysis.

• Knowledge of medical device design control, risk management, and regulatory

standards (ISO 13485, FDA QSR).

Skills Required