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Senior R&D Mechanical Engineer
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-01-12
Listing for:
I3 INFOTEK INC
Full Time
position Listed on 2026-01-12
Job specializations:
-
Engineering
Product Engineer, Mechanical Engineer
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.
- 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.
- 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 LevelAssociate
Employment TypeContract
Job FunctionHospitals and Health Care
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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