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I3 INFOTEK INC

Senior R&D Mechanical Engineer

I3 INFOTEK INC, Irvine, California, United States, 92713

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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.

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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