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Senior R&D Mechanical Engineer
Senior R&D Mechanical EngineerI3 INFOTEK INC • Irvine, CA, US
Senior R&D Mechanical Engineer

Senior R&D Mechanical Engineer

I3 INFOTEK INC • Irvine, CA, US
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Job Description

The Senior R&D Mechanical Engineer will be responsible for leading mechanical design activities, supporting product development, and collaborating with cross-functional teams for medical device projects. The ideal candidate will have strong hands-on experience in SolidWorks, product lifecycle management, and the development of regulated medical products.

Key Responsibilities

  • Lead mechanical design of components and assemblies using SolidWorks (Parts, Assemblies, and Engineering Drawings).
  • Drive product development activities from concept through verification, validation, and commercialization.
  • Utilize Windchill PLM for change management, document control, and lifecycle processes (added advantage).
  • Support engineering teams across onsite and offshore locations; ensure design alignment and timely deliverables.
  • Collaborate with cross-functional teams including manufacturing, quality, regulatory, and supply chain.
  • Conduct feasibility studies, tolerance analysis, and design reviews to ensure robust product designs.
  • Support Verification & Validation (V&V) activities, including test method development, execution, and documentation.
  • Ensure compliance with medical device industry standards (ISO, FDA, GMP).
  • Generate clear engineering documentation such as design specifications, test reports, and change notices.
  • Communicate effectively with internal stakeholders, external vendors, and cross-functional partners.

Required Skills & Experience

  • 9–11 years of experience as a Mechanical Engineer, preferably in medical device R&D
  • Strong proficiency with SolidWorks (Part modeling, Assemblies, Drawings).
  • Hands-on experience with Product Lifecycle Management (PLM) tools; Windchill experience preferred.
  • Experience with medical device product development processes, including design controls, V&V, and risk management.
  • Proven ability to coordinate across onsite and offshore teams.
  • Excellent communication, interpersonal, and team collaboration skills.
  • Nice to Have

  • Experience working with Johnson & Johnson or similar regulated industry clients.
  • Exposure to automation, fixture design, or prototyping techniques.
  • Employment Details

    Job Type : Contract

    Experience Required : 9–11 Years

    Qualification : Bachelor of Technology / Engineering

    Work Authorization : Any visa except H1

    Work Mode : Onsite

    Duration : Long-term contract (potential extension)

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