R D Engineer

ALIGN Executive Search; Tustin (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

ALIGN Executive Search is seeking a biomedical/mechanical/materials engineer for a regulated medical device environment in California. You will design, prototype, test, and document, ensuring regulatory compliance while supporting product transfer and IP growth. A BS or higher with 2+ years of relevant experience is required.

The role involves hands-on lab work, creating tools and fixtures, and maintaining the Design History File to support FDA submissions and ISO/QSR standards.

Qualifications

• Education: Bachelor’s degree or higher in Biomedical, Mechanical, or Materials Engineering.
• Experience: Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry.
• Technical Skills: SolidWorks proficiency for 3D modeling and engineering drawings.

Responsibilities

• Design & prototyping: build sketches, 3D models, detailed concepts, and prototypes.
• Testing & validation: plan and run benchtop tests, V&V, and pre-clinical studies with clear reports.
• Tooling: create tools, jigs, and fixtures for testing, prototyping, and manufacturing.
• Documentation: write drawings, risk analyses, specs, and maintain DHF for regulatory compliance.
• Collaboration: assist with product transfer, scale-up, and IP growth.
• Lab support: maintain clean, organized R&D lab for prototype development.

Skills

Problem solving

Technical writing

Education

Bachelor’s degree in Biomedical, Mechanical, or Materials Engineering

Tools

SolidWorks

Job description

Essential Job Functions

• Design & Prototyping: Build preliminary sketches, 3D models, detailed design concepts, and engineering prototypes. [1]
• Testing & Validation: Plan and run benchtop tests, verification and validation (V&V), and pre-clinical studies, writing clear protocols and reports. [1]
• Tooling: Make tools, jigs, and fixtures to help with testing, prototyping, and manufacturing. [1]
• Documentation: Write product drawings, risk analysis, specifications, and keep the Design History File (DHF) updated for regulatory compliance. [1]
• Collaboration: Help with product transfer, scale-up activities, and share new ideas to grow the company's patent and intellectual property base. [1]
• Lab Support: Keep the R&D lab clean and organized for smooth prototype development. [1]

Job Requirements

• Education: Bachelor’s degree or higher in Biomedical, Mechanical, or Materials Engineering. [1]
• Experience: Minimum of 2 years of engineering experience in product development or manufacturing within a regulated medical device industry. [1]
• Technical Skills: Strong working knowledge of SolidWorks for 3D modeling and engineering drawings. [1]
• Core Skills: Good problem-solving abilities, strong technical writing skills, and familiarity with FDA submissions, ISO standards, and Quality System Regulations (QSR)

Compensation:
$100,000 per year