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Senior R&D Mechanical Engineer

Job in Irvine, Orange County, California, 92713, USA
Listing for: I3 INFOTEK INC
Full Time position
Listed on 2026-01-12
Job specializations:
  • Engineering
    Product Engineer, Mechanical Engineer
Salary/Wage Range or Industry Benchmark: 100000 - 125000 USD Yearly USD 100000.00 125000.00 YEAR
Job Description & How to Apply Below

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 Solid Works, product lifecycle management, and the development of regulated medical products.

Key Responsibilities
  • Lead mechanical design of components and assemblies using Solid Works (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 Solid Works (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.

Job Type: Contract

Experience

Required:

9–11 Years

Qualification: Bachelor of Technology / Engineering

Work Mode: Onsite

Seniority Level

Associate

Employment Type

Contract

Job Function

Hospitals and Health Care

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Position Requirements
10+ Years work experience
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