Design Verification Test Engineer I at THE EMPLOYEE CONNECT in Goleta, California, United States

Job description

• Our client, a medical device manufacturer, is seeking two Design Verification Test Engineers for onsite contract engagements in Goleta, California, running approximately seven months. The role verifies that new and modified medical devices meet their design requirements before they reach clinical use. This is meaningful engineering work in a regulated environment where testing rigour has direct patient safety consequences.

Responsibilities

• You will develop design verification test protocols that trace directly to product requirements and design inputs, defining test methods, sample sizes, acceptance criteria, and statistical rationale in line with the design control process
• You will execute verification testing on device hardware and systems, which may include functional, electrical, mechanical, environmental, and reliability testing, operating test equipment and fixtures correctly and recording raw data with full traceability
• You will analyse test results against acceptance criteria, investigate failures and anomalies to root cause, support corrective action where a design or test method issue is identified, and author clear verification test reports suitable for inclusion in the design history file and regulatory submissions
• You will support test fixture and method development, participate in design reviews and risk management activity, contribute to test method validation, and work closely with design engineering, quality, and regulatory colleagues throughout the product development lifecycle
• You will maintain the traceability that connects requirements, verification protocols, executed tests, and results, ensuring the record stands up to audit and supports regulatory submission without rework
• You will also manage test sample logistics including build coordination, sample accountability, equipment calibration status verification, and laboratory scheduling so that testing runs to plan

Requirements

• A bachelor's degree in engineering, such as biomedical, mechanical, electrical, or a closely related discipline, is required, or equivalent demonstrated experience in a test engineering role
• You must have hands-on testing experience in a product development or manufacturing environment, including protocol execution, data collection, and technical report writing
• Strong technical documentation skills and disciplined attention to detail are essential, given the regulated nature of the work
• Practical competency with test equipment and measurement instrumentation, data analysis capability, and the ability to work onsite in Goleta, California for the full assignment are required
• Prior medical device industry experience is strongly preferred, along with working familiarity with design control requirements under 21 CFR Part 820 and ISO 13485
• Exposure to IEC 60601 electrical safety testing, risk management under ISO 14971, statistical analysis and sample size justification, and test automation or scripting in tools such as Python or LabVIEW are all highly valued
• Experience with electromechanical devices, optics, or imaging systems is valued depending on product line
• Familiarity with design of experiments, reliability and life testing, package and sterilization validation, and change control processes for design modifications are all advantageous, as is exposure to verification activity supporting FDA submissions

Skills

Required

• Hands-on testing experience
• Protocol execution
• Data collection
• Technical report writing
• Strong technical documentation skills
• Disciplined attention to detail
• Data analysis capability

Preferred

• Medical device industry experience
• IEC 60601 electrical safety testing
• Risk management under ISO 14971
• Design of experiments
• Reliability and life testing
• Package and sterilization validation