Senior R&D Mechanical Engineer

I3 INFOTEK INC; Irvine (CA); On-site; USD 100,000 - 130,000; Full time

Job summary

A leading engineering company is seeking a Senior R&D Mechanical Engineer to lead design activities for medical device projects. The ideal candidate will have 9-11 years of experience, strong proficiency in SolidWorks, and a background in product lifecycle management. The role involves collaborating with cross-functional teams to ensure compliance with industry standards, conducting design reviews, and generating engineering documentation. This is a contract position based in California, with a focus on hospitals and health care.

Qualifications

• 9–11 years of experience as a Mechanical Engineer in medical device R&D.
• Strong proficiency with SolidWorks for modeling and documentation.
• Hands-on experience with PLM tools, especially Windchill.

Responsibilities

• Lead mechanical design of components using SolidWorks.
• Drive product development from concept through commercialization.
• Support V&V activities for medical device projects.

Skills

SolidWorks

Product Lifecycle Management (PLM)

Medical device R&D

Communication skills

Team collaboration

Education

Bachelor of Technology / Engineering

Tools

Windchill PLM

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.

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