Research & Development (R&D) Engineering
5 days ago
Position Overview The R&D Engineer will support product development activities within the medical device domain, contributing to the design, documentation, and improvement of products in accordance with regulatory and quality standards. The ideal candidate will have solid hands-on experience with SolidWorks, familiarity with Windchill change management, and exposure to validation and verification (V&V) processes.
Key Responsibilities
Perform mechanical design and modeling using SolidWorks to support new product development and engineering changes.
Create and maintain engineering drawings, 3D models, and assemblies following J&J standards.
Support change management activities in PTC Windchill , including documentation updates, ECO/ECR processing, and configuration control.
Assist in the development and execution of Validation & Verification (V&V) protocols, test methods, and reports.
Contribute to the overall medical device product development lifecycle , ensuring designs meet quality, reliability, and regulatory requirements.
Collaborate cross-functionally with R&D, Quality, Manufacturing, and Project Management teams.
Participate in design reviews, provide technical feedback, and ensure design documentation accuracy.
Support problem-solving activities, root cause investigations, and implementation of corrective actions as needed.
Maintain effective communication, documentation accuracy, and adherence to company procedures.
Required Qualifications
~1–2 years of experience with SolidWorks (modeling, drafting, assemblies).
~ Experience with Windchill (preferably Engineering Change Management processes).
~ Background in Medical Device product development or regulated industry.
~ Knowledge of Validation & Verification (V&V) practices.
~ Strong communication, teamwork, and interpersonal skills.
Preferred Qualifications
Experience in FDA-regulated environments (21 CFR 820, ISO 13485).
Hands-on experience in prototyping, testing, or verification lab environments.
Exposure to risk management (ISO 14971).
Employment Details
Contract Role
Onsite in Irvine, CA
Visa: Any except H1B
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