Research And Development Engineer

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 Solid Works, familiarity with Windchill change management, and exposure to validation and verification (V&V) processes.

• Perform mechanical design and modeling using Solid Works 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.

• 1–2 years of experience with Solid Works (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.

• 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).
• Contract Role
• Onsite in Irvine, CA
• Visa: Any except H1B

Associate

Contract

Engineering and Research

Hospitals and Health Care