Capillary Biomedical is a medical device startup developing technologies for diabetes management. We aim to dramatically simplify insulin delivery, reducing the burden on both patients and the overall healthcare system. CapBio’s kink-proof, super-soft cannula features multi-port delivery for reliable, and comfortable insulin delivery. The company is based in Irvine, CA and is a spin-out of the Artificial Pancreas Center at the Sidney Kimmel Medical College of Thomas Jefferson University in Philadelphia, PA.
Our R&D department is expanding rapidly in order to meet demand for a highly anticipated product. Key focus will be on design Verification and Validation activities in support of an FDA filing, supporting clinical trials, and manufacturing process scale-up support. This position is part of a highly dynamic team in fast-pace work environment.
Performs and documents laboratory testing in support of Product Development.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
– Develop and perform testing on prototype and production product to support Product Development engineers
– Perform testing using an automated vertical tension and compression machine
– Perform flow testing using various flow measurement and pressure systems
– Develop and maintain lab apparatus and test methods
– Maintain performance and calibration of lab equipment
– Prepare sample product for testing and maintain proper documentation for product traceability
– Assist in ordering lab supplies, standards, solvents and tracking inventory
– Work with Product Development and Quality Engineers to improve existing testing methodologies and SOPs to increase lab efficiency
– Properly document all work on appropriate forms as required by test protocols and SOPs
– Utilize and maintain a laboratory notebook
– Comply with safety and operating policies and procedures regarding equipment, materials, and the finished product
– Maintain good work place organization and housekeeping
– Maintain a safe work environment; thoroughly read and understand the material safety data sheets (SDS) for proper handling of materials, follow operating and maintenance instructions for tools and machinery, and utilize relevant manuals for proper operating procedures
– Performs verification and validation activities in accordance with company QMS, ISO, and FDA standards
– Understands and applies GDP, GLP, and GMP
– Must work well in dynamic group environment, be a self-starter, and manage multiple tasks at once
QUALIFICATIONS (Minimum 3 years work related experience)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
Associates Degree (A.S.) or Technology Certification in Engineering with verifiable experience in a biomedical lab testing environment required. Bachelor’s degree (B.A.) from four-year college or university in biomedical, chemical, or mechanical engineering desirable but not required.
Ability to effectively communicate with Product Development engineers about test equipment and methods. Ability to work in both a team environment and individually in support of Product Development goals. Ability to generate test protocols and reports in proper formats. Ability to record test data in Excel or other formats as required by test protocols. Ability to effectively communicate with equipment vendors.
Ability to calculate figures and amounts as required by testing protocols. Ability to apply concepts of basic algebra and geometry.
Ability to define problems, collect data, establish facts, and draw valid conclusions as related to test protocols and procedures. Ability to interpret technical instructions in order to maintain and utilize test equipment and apparatus.
Ability to run various computer programs to support lab equipment and testing apparatus required. Competency with Microsoft Office Suite and computerized QMS systems as required by job responsibilities.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
– While performing the duties of this job, the employee is constantly required to sit and use hands to operate telephone, type and operate computer and mouse. The employee is frequently required to talk, hear, and bend and twist neck. The employee may occasionally lift and/or move up to 10 pounds and rarely lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
– While performing the duties of this job, the employee is in a typical office environment. The noise level in the work environment is usually moderate, but occasionally noisy.