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&DStrong 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.Employment Details
Job Type : Contract
Experience Required : 9–11 Years
Qualification : Bachelor of Technology / Engineering
Work Authorization : Any visa except H1
Work Mode : Onsite
Duration : Long-term contract (potential extension)