Design and develop innovative mechanical solutions to improve performance, safety, reliability, throughput and cost-effectiveness (Knowledge of Should costing and estimation), in Design Change Project.
Act as a change lead, managing the entire Design change process independently.
Handle multiple projects with proper project planning and minimal guidance
Conduct root cause analysis and implement corrective actions.
Collaborate with cross function teams to resolve manufacturing and field issue, conduct feasibility studies, risk assessments, and design reviews and validate designs through analysis and testing.

The essential requirements of the job include:

Bachelor s degree in mechanical engineering or a related field with 5 years of experience in mechanical design principles, materials, manufacturing processes.
Proficiency in SolidWorks CAD software and simulation tools.

Create and maintain detailed engineering documentation, including CAD models, drawings, specifications and test plans.
Knowledge of dFMEA/pFMEA, DFX, Tolerance Stack-up Analysis and GD&T

Basic knowledge of metals and materials, its application knowledge on mechanical parts fabrication, Rapid prototyping and testing.

It would be a plus if you also possess previous experience in:

Experience with medical device regulations (FDA, ISO 13485, ISO 14971, IEC 60601)
Experience in IVD instrumentation, such as clinical chemistry, immunoassay, hematology, urinalysis, molecular, microbiology or flow cytometry systems is a plus
Advanced certification in CAD tools
Familiarity with lean manufacturing and Six Sigma principles.
Prior work experience in Electro-Mechanical products, Robotics and Automation

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