We are extremely passionate about two things: our talented team of Cardeans and our bold vision of having “Powered by Cardea” products and applications impact and transform our lives from human health, agriculture, food and water safety, diagnostics, biosafety to the environment.
We are linking computers directly up to the live signals of biology for the very first time by building a Tech+Bio Infrastructure with chipsets based on our proprietary Biology-gated Transistors, or Cardean Transistors™. These electronic transistors leverage graphene, a nanomaterial that in contrast to the common semiconductor material silicon, is biocompatible and acts as a near perfect conductor. The result is a powerful paradigm-shift in life science, replacing optical “single snapshot” observations with electronic systems that can capture interactive live-streams of multi-omics signal analysis in real-time. Together, with our Innovation Partners, our technology enables the translation of real-time biological signals into digital information to provide immediate biological insight.
We are rapidly growing and looking for talented people who are self-driven, enjoy wearing many hats, and thrive in a collaborative environment. Join us in building a new generation of natural resources and applications that can Link up to Life™.
About the Role
The ideal candidate for this role will have previous experience in medical device or life science diagnostics manufacturing and proven experience in process steps requiring fine motor skills and attention to detail. Also, the candidate will be experienced with good manufacturing processes and good manufacturing practices. We are looking for someone who has the dedication and focus to perform their tasks consistently, accurately, and with reproducible results. The candidate will report to the production engineer and will focus on finished goods manufacturing steps involving repeat and precise hand-assembly; inventory management of production supplies; setup and maintenance of clean room and production equipment; and support of process improvement efforts and quality control activities.
Responsibilities, but not limited to
- Assemble components of medical diagnostic devices in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs).
- Consistent performance of dexterous operations such as graphene transfer from water baths onto silicon wafers and liquid/electrical testing of Cardean chips.
- Perform bench processes to complete mechanical, electrical, and optical assemblies using hand and electronic equipment.
- Prepare reagents and perform production related tasks per established Work Instructions.
- Perform QA and QC processes to test products for functionality and quality. Measure and record data associated with QA and QC.
- Responsible for recognizing product or equipment problems that arise during the manufacturing process.
- Identify opportunities for improvements to the process and lead projects designed to implement those improvements.
- Performing work order processing to complete products to inventory.
- Support preparation of production documents, such as standard operating procedures, manufacturing batch records, inventories, or productivity reports as needed.
- Provide production, progress, changeover reports, or data analysis reports to supervisors.
- Identify problems, safety concerns, and suggest improvements.
- Ensures equipment operates within expected run and reject rates.
- Perform in-process quality checks on sub-assemblies and finish products.
- Identify line issues and other production problems; promptly notify Team Leader or Supervisor of all problems.
- Completes all manufacturing documents including Device History Records (DHRs) and machine and material use (reconciliation for yields, returns, scrap).
- Receive, pack, and ship items as necessary.
- Maintain a clean and orderly work area.
- Continually work to achieve assigned production goals.
- Prevent mix-up of products, materials, labels, and other components.
- Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes.
- Other duties as assigned.
- High school diploma and 1 year of related experience, or equivalent combination of education and experience.
- Required manufacturing experience of regulated devices, such as medical or life science, demonstrating adherence to GMP and other regulations. Ability to understand and adhere to QSRs, GMP and ISO requirements.
- Proven experience with hand-assembly requiring repeatable, consistent dexterity, eye for quality, and exacting documentation.
- Ability to read and interpret documents such as safety rules, operating procedures, and maintenance instructions.
- Working knowledge with Microsoft Office (Word, Excel, Outlook).
- Ability to communicate effectively through oral and written communications.
- Ability to work with others collaboratively.
- Ability to analyze and solve problems.
- Ability to frequently sit, stand, walk, reach with hands and arm’s length, climb or balance, stoop, kneel, and crouch.
- Ability to regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds.
- Specific vision requirements include close vision and color vision.
- Must be willing and able to conform to cleanroom practices with regard to apparel and personal hygiene.
- Onsite at Cardea’s San Diego location