Job Title: R&D Test Engineer
Location: Irvine, CA
Employment Type: Full-Time
Position Overview
We are seeking R&D Test Engineers to support the development and verification of innovative drug delivery and medical device products. The selected candidates will contribute to verification and validation activities, test method development, and product testing to ensure compliance with regulatory and internal quality standards.
This role involves working closely with cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs to support product development, verification strategies, and root cause investigations.
Key Responsibilities
- Assist in the development and testing of innovative drug delivery products.
- Define and execute verification strategies, including development of verification plans, protocols, records, and reports.
- Develop scientifically justified sample size strategies in compliance with internal and regulatory requirements.
- Design and execute engineering and verification test procedures.
- Prepare test protocols and documentation, maintain accurate laboratory notebooks, and present results to cross-functional teams.
- Analyze test data and provide technical insights and recommendations.
- Lead or support root cause investigations and implement issue resolutions.
- Define, develop, and validate test methods for product verification.
- Recommend design, process, or project improvements to enhance product performance and development efficiency.
- Ensure compliance with company policies, regulatory standards, and safety procedures.
- Review and evaluate design changes for technical and regulatory compliance.
- Conduct tests to determine physical and mechanical characteristics of materials for quality control, process control, and product development.
- Perform technical tasks according to quality and functional standards.
Required Qualifications
R&D Test Engineer
- Experience in R&D testing, product development, or verification within engineering environments.
- Strong experience in verification planning, protocol development, and testing execution.
- Demonstrated ability to lead root cause investigations and technical problem-solving.
- Experience working in regulated industries (medical devices preferred).
- Strong technical documentation and cross-functional communication skills.
- experience in engineering testing, product development, or laboratory environments.
- Basic knowledge of engineering test methods and verification processes.
- Ability to perform testing, data analysis, and documentation under supervision.
- Strong analytical and problem-solving skills.
Preferred Skills & Tools
Experience with the following tools and technologies is preferred:
Testing & Lab Equipment
- Zwick or Instron testing systems
- Flow measurement equipment
- Viscometers
- Climate chambers
- 3D printing technologies
Engineering & Data Tools
- SolidWorks
- Minitab
- Electronic Lab Notebook (ELN)
Project & Requirements Management
- Microsoft Project
- Laboratory Information Management Systems (LIMS) such as LinkUS
- Requirements and Risk Management tools such as DOORS or Cockpit
