Senior R&D Mechanical Engineer

5 days ago

Irvine, United States I3 INFOTEK INC Full time

Job DescriptionThe 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 ResponsibilitiesLead 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 & Experience911 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 HaveExperience working with Johnson & Johnson or similar regulated industry clients.Exposure to automation, fixture design, or prototyping techniques.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)

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