Research And Development Engineer

I3 INFOTEK INC; Irvine (CA); On-site; USD 85,000 - 110,000; Part time

Job summary

A leading technology company in California is seeking an R&D Engineer to support medical device product development. This role involves mechanical design using SolidWorks, V&V processes, and collaboration with cross-functional teams. Candidates must have 1-2 years of SolidWorks experience and familiarity with Windchill. This is a contract position, requiring onsite presence in Irvine, CA, except for H1B visa holders. Strong communication and teamwork skills are essential for success.

Qualifications

• 1–2 years of experience with SolidWorks for modeling, drafting, and assemblies.
• Experience with Windchill, preferably in Engineering Change Management.
• Background in Medical Device product development or regulated industry.
• Knowledge of Validation & Verification (V&V) practices.
• Strong communication, teamwork, and interpersonal skills.

Responsibilities

• Perform mechanical design and modeling using SolidWorks.
• Create and maintain engineering drawings and 3D models.
• Support change management activities in PTC Windchill.
• Assist in the development and execution of V&V protocols.
• Collaborate with R&D, Quality, Manufacturing, and Project Management.
• Collaborate with R&D, Quality, Manufacturing and Project Management teams.
• Participate in design reviews, provide technical feedback, and ensure documentation accuracy.
• Support root cause investigations and corrective actions when issues arise.
• Maintain clear communication and documentation per procedures.

Skills

SolidWorks

Windchill

Validation & Verification (V&V)

Communication

Teamwork

Tools

SolidWorks

Windchill

Job description

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

Seniority level

Associate

Employment type

Contract

Job function

Engineering and Research

Industries

Hospitals and Health Care