Fulltime : Mechanical Engineer - 5+ years (Onsite)

Company Name : WillWare Technologies

Work Model : Fulltime / Onsite

Work Location : Bangalore

Experience : 5+ Years

Role & 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. Qualifications & Skills: Education: • Bachelors or Master’s degree in Mechanical Engineering, or related field from reputed institutes (IIT, NIT,.. etc.) 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).