R & D Engineer

ALIGN Executive Search • Tustin, CA

9h

About The Position

The R&D Engineer will be responsible for designing and prototyping new products, conducting tests and validation, creating necessary tooling, documenting designs for regulatory compliance, collaborating on product transfer and scale-up, and supporting the R&D lab. This role requires a strong understanding of engineering principles and experience in the medical device industry.

Requirements

• Bachelor’s degree or higher in Biomedical, Mechanical, or Materials Engineering.
• Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry.
• Strong working knowledge of SolidWorks for 3D modeling and engineering drawings.
• Good problem-solving abilities.
• Strong technical writing skills.
• Familiarity with FDA submissions, ISO standards, and Quality System Regulations (QSR).

Responsibilities

• Build preliminary sketches, 3D models, detailed design concepts, and engineering prototypes.
• Plan and run benchtop tests, verification and validation (V&V), and pre-clinical studies, writing clear protocols and reports.
• Make tools, jigs, and fixtures to help with testing, prototyping, and manufacturing.
• Write product drawings, risk analysis, specifications, and keep the Design History File (DHF) updated for regulatory compliance.
• Help with product transfer, scale-up activities, and share new ideas to grow the company's patent and intellectual property base.
• Keep the R&D lab clean and organized for smooth prototype development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level