Company Description

Biotex specializes in the development, launch, and manufacturing of medical and bio-technologies. We partner with entrepreneurs, start-ups, and established companies to bring concepts to life with a full spectrum of medical device development and manufacturing. The company is committed to innovating and developing novel solutions to medical, biomedical, and bio-technology problems with a focus on early-stage development of diagnostic and therapeutic medical devices.

Role Description

Criterion is the ISO 17025 accredited testing services department within Biotex, Inc. This is a full-time on-site role for a Test Engineer II located in Houston, TX. The Test Engineer II will be responsible for test engineering, test execution, creating test cases, testing, and functional testing within the medical device development and manufacturing environment.

Job Functions:

• Write test plans, perform testing, and author reports based on compliance standards.
• Able to set up test equipment and write/maintain equipment operating procedures.
• Train and provide guidance to test technicians as required.
• Perform troubleshooting of test equipment and equipment under test as needed and communicate any performance issues as they occur.
• Perform assessments for proposed design changes and provide design recommendations to product development engineers and management.
• Complete professional level engineering assignments related to product safety, EMC, packaging, verification and validation (V&V), etc. and provide design recommendations to product development engineers and managers.
• Lead and participate in projects involving the design, fabrication, and manufacture of complex medical subassemblies, systems or processes.
• Develop, integrate, verify, and validate test methods.
• Travel as necessary to aid in program facilitation or for training (10%).

Expected Skills/Attributes

• IEC 60601-1 testing experience is a requirement.
• A proven self-starter with the highest level of integrity in the successful completion of your work.
• Strong technical background and knowledge of the product safety, EMC, packaging, or medical V&V testing procedures/standards.
• Advanced organizational skills and attention to detail.
• Excellent oral and written communication and documentation skills.
• Pro-active problem-solving skills.
• The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
• Must be able to collaborate with multi-disciplinary groups and functions on site.
• Effectively interface with external certification agencies.
• Ability to adapt and work in an FDA regulated environment.
• Knowledge of regulations and standards affecting the medical device industry is a plus.

Minimum Qualifications

• Bachelor’s or Master’s degree in relevant field with more than 3 years relevant experience or PhD with more than 1-year relevant experience.