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# Design Engineer

- **Company:** Intellectt, Inc
- **Location:** Ontario, CA, United States
- **Experience:** Expert
- **Salary:** $70,720.0 - $74,880.0
- **Contract:** Permanent contract
- **Skills:** SolidWorks (CAD), Failure Mode Effects Analysis, Creo
- **Published:** July 11, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=7fb4d342610da1ff

## About the Role

* Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
 * 5+ years of medical device design and development experience.
 * Experience with Class II and/or Class III medical devices.
 * Strong proficiency in SolidWorks or Creo.
 * Hands-on experience with GD&T, DFMEA, V&V, DFM, and Design Controls.
 * Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
 * Excellent communication, analytical, and problem-solving skills., * Experience with injection molding, machining, plastics, and metal components.
 * Familiarity with IEC 60601.
 * Experience supporting regulatory submissions and product commercialization.

## Description

We are seeking a Senior Design Engineer with 5+ years of experience in medical device product design and development. The ideal candidate will lead the design and development of Class II/III medical devices from concept through commercialization while ensuring compliance with industry regulations and quality standards., * Design and develop medical device components and assemblies.

 * Create and review 3D CAD models and engineering drawings using SolidWorks or Creo.
 * Perform GD&T, DFMEA, Design Verification & Validation (V&V), and Design for Manufacturability (DFM).
 * Support prototype development, testing, product improvements, and commercialization.
 * Collaborate with Manufacturing, Quality, Regulatory, and R&D teams.
 * Ensure compliance with FDA, ISO 13485, ISO 14971, and medical device design controls.
 * Support manufacturing transfer, design changes, and product launch activities.


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