Senior R&D Mechanical Engineer (Irvine)

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

Nice to Have

Employment Details

Job Type : Contract

Experience Required : 911 Years

Qualification : Bachelor of Technology / Engineering

Work Authorization : Any visa except H1

Work Mode : Onsite

Duration : Long-term contract (potential extension)