Staff Manufacturing Engineer, CMO Support - Pleasanton, CA

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.

Summary:

The Staff Manufacturing Engineer will take a leadership role primarily to support transfer and sustaining manufacturing activities at our Contract Manufacturing Organization (CMO) in Costa Rica and Mexico.   This individual will collaborate cross-functionally and with suppliers to ensure the successful scaling and sustained success of our internal and external medical device manufacturing processes.  Additionally,  they will lead identification and implementation of process improvements that improve product quality, manufacturability, and production throughput.

In This Role, You Will:

• Lead and drive technical projects leading to new/improved processes for CVAC 2.0.
• Partner cross-functionally 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.
• Oversee the design and development of 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:

• Director, Manufacturing

Requirements:

• Education: Bachelor of Science in Engineering or a combination of relevant education and experience
• Minimum 10 years’ progressive experience supporting medical device manufacturing at a CMO
• Work location: Pleasanton, CA
• Travel: up to 50%
• Full time employment
• Proven track record of leading and delivering highly technical projects in a cross functional environment.
• Experience working in a structured design process such as ISO9000 or FDA QSR and knowledge of regulatory approval process and requirements.
• Working knowledge of Design Control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485 or ISO9001 and EN46001.
• Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks.
• Desirable: Experience with electronic components/assembly in the context of medical device capital equipment.
• Desirable: Experience designing, building, and implementing manufacturing fixtures and processing aids.
• Highly desirable: Bilingual/proficiency in Spanish.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

What We Offer:

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team.  You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture.  You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself. 

We also offer a compensation plan as follows:

• Competitive salary of $150,000 - $180,000 and variable in