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Product Development Engineer I

TekOne IT Services Pvt. Ltd.
Irvine, CA Full Time
POSTED ON 12/9/2024
AVAILABLE BEFORE 4/6/2025
Role: Product Development Engineer I

Location: Irvine, CA

Duration; 06 Months

Job Summary

We are seeking a skilled and creative Medical Device Senior Mechanical CAD Designer / Design Engineer to support our product engineering team. This person will be responsible for designing, developing, and updating medical devices using SolidWorks and possibly On shape CAD software. This role requires a strong understanding of mechanical/electromechanical design and drafting principles, including application of GD &T, Design for Manufacturing, and proficiency in CAD modeling. The successful candidate will work closely with R&D, Manufacturing, and Quality Assurance to develop/modify CAD models and drawings for our Aurora products.

Key Responsibilities

  • Create/modify/update detailed 3D models and 2D drawings for medical device components and assemblies using Solidworks CAD software.
  • Work with R&D and Manufacturing Engineering to update existing product designs to incorporate Design for Manufacturing elements and create/update drawings with proper dimensioning and ensure compliance to the ASME Y14.5 GD&T Standard.
  • Analyze and optimize designs for manufacturability, cost-effectiveness, and performance.
  • Generate and maintain detailed design documentation, including CAD drawings, design history files, and engineering change orders (ECOs)
  • Work closely with cross-functional teams including mechanical, electrical, and software engineers to ensure seamless integration of device components. Communicate effectively with stakeholders at all levels.

Education

  • 6-10 years of experience in CAD design for medical devices or similar products is required
  • Bachelor’s degree in mechanical engineering, biomedical engineering, or a related field is desired but not required

Technical Skills

  • 3D Solid Model CAD training is required
  • Proficiency in CAD software (specifically SolidWorks) is required
  • Knowledge and experience in application of GD&T (Geometric Dimensioning and Tolerancing), in alignment with the ASME Y14.5 GD&T Standard is required
  • Design for Manufacturing knowledge is required
  • Familiarity with FEA (Finite Element Analysis) and other design analysis tools is desired
  • Understanding of materials used in medical devices is desired

Soft Skills

  • Strong analytical and problem-solving skills, excellent communication and teamwork abilities, and attention to detail are desired

Certifications

  • Relevant certifications (e.g., Certified SolidWorks Professional) are desired.

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