Job Summary: The LCM Test Engineer will be responsible for developing and optimizing test methods, automating test setups, and supporting verification and characterization activities for medical device components. The role involves designing test fixtures, performing prototype testing, evaluating manufacturing processes, and collaborating with cross-functional teams to ensure device performance and compliance within the medical device development lifecycle.
Location: Irvine, California (Relocation Required)
Experience: 8-10 Years
Key Responsibilities:Test Method Development & Automation- Develop and optimize test methods to support characterization and verification of medical device components.
- Automate simulated-use test setups to reduce manual intervention and increase testing throughput.
- Build test scripts, instrument control logic, and automation solutions to streamline testing workflows.
- Support extended continuous testing cycles through automation and system optimization.
Prototyping & Fixture Development- Design, prototype, and refine 3D-printed test fixtures for early-stage prototype evaluation and pre-clinical testing.
- Construct and assemble sample components for device performance testing, feasibility studies, and product characterization.
- Support engineering teams with prototype testing and validation activities.
Process & Equipment Evaluation- Evaluate and optimize settings on manufacturing printers or additive manufacturing systems to produce high-density multi-electrode components.
- Perform experiments to improve electrode impedance and signal-to-noise ratio (SNR).
- Collaborate with manufacturing engineers to ensure test findings support scalable production processes.
Data Collection, Analysis & Reporting- Analyze test data and summarize results to provide actionable insights to R&D, quality, and manufacturing teams.
- Maintain accurate engineering documentation including test protocols, technical reports, and test results.
- Ensure proper documentation for verification and validation activities.
Required Skills & Experience:- 8-10 years of experience in testing engineering within the medical device industry.
- Strong knowledge of test method development, automation, and device verification processes.
- Experience designing and developing test fixtures and prototype assemblies.
- Experience with device performance testing, pre-clinical testing, and verification activities.
- Ability to create and automate test scripts and instrument control logic.
- Strong analytical, troubleshooting, and problem-solving skills.
- Excellent written and verbal communication skills in English.
Competencies:- Strong documentation and technical reporting capabilities.
- Ability to multitask and manage multiple engineering tasks simultaneously.
- Ability to follow complex procedures and work in a regulated environment.
- Strong collaboration skills with cross-functional teams including R&D, quality, and manufacturing.
Preferred Skills:- Experience with additive manufacturing or high-precision manufacturing systems.
- Knowledge of medical device regulatory requirements and quality standards.
- Experience improving signal quality metrics such as impedance and signal-to-noise ratio.
- Familiarity with device lifecycle management and verification validation processes.
