Manufacturing Engineer

2 weeks ago


Pleasanton, United States Calyxo USA Inc Full time

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

In This Role, You Will:

  • Initiate, own, and complete technical projects leading to new/improved processes for CVAC 2.0.
  • Work closely with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability.
  • Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety
  • Provide sustaining production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
  • Train and support production personnel during transition of new products/processes to production.
  • Generate and modify high-quality manufacturing process documentation and assure that processes and documentation follow established policies and procedures.
  • Utilize LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.
  • Assist in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.
  • Generate and modify component/assembly/equipment drawings using Solidworks.
  • Write and execute process and equipment validations (IQ/OQ/PQ).
  • Work with external vendors as needed.
  • Perform equipment maintenance by following manufacturer's instructions and established procedures.
  • Effectively communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines.
  • Ensure product quality and support regulatory compliance.
Who You Will Report To:
  • Senior Manufacturing Engineer
Requirements:
  • Education: Bachelor of Science in Engineering or a combination of relevant education and experience
  • Minimum 3 years' experience supporting medical device manufacturing
  • Work location: Pleasanton, CA
  • Travel:


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