Mechanical Engineer

Role: Mechanical Engineer

Experience: 5+ Years

Location: Bengaluru

Key Responsibilities:

Design & Development

Lead end-to-endmechanicaldesign of electromechanicalmedical 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 andmechanicalcalculations to validate design robustness.

Select materials and manufacturing processes (injection moulding, machining, casting,

sheet metal, etc.) suitable for medical applications.

Supportengineeringbuilds and hands-onmechanicaltesting 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 maintainengineeringdocumentation, 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

mechanicalintegration.

Coordinate with quality, regulatory, and manufacturingengineeringteams

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 inmechanicaldesign for medical devices

Successfully worked as designengineerand 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).