Senior Process Development Engineer - 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.

The Senior Process Development Engineer will play a key part in product development by creating and optimizing manufacturing processes for new instruments. The role partners with R&D, Quality, and other cross-functional groups to ensure that new designs are manufacturable and scalable. The engineer will also be responsible for transferring new designs/processes into production, both locally and at international contract manufacturers.

• Initiate, own, and complete technical projects resulting in new/improved processes for Calyxo products.
• Effectively communicate project status, schedule baselines, schedule issues, project risks, and major decisions across all company disciplines.
• 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, both locally and at international contract manufacturer.
• Generate and modify high-quality manufacturing process documentation and ensure 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 Solid Works.
• Write and execute process and equipment validations (IQ/OQ/PQ).
• Ensure product quality and support regulatory compliance.

• Manager, Process Development Engineering

• Education:
  
  BS in Engineering or a combination of relevant education and experience.
• Minimum of 8 years of experience supporting medical device manufacturing. Experience with catheter manufacturing processes desired.
• Work location:
  
  Pleasanton, CA
• Travel: 10%
• Full time employment
• Experience in leading highly technical projects in a cross functional environment.
• Experience working in a structured design process such as ISO
  9000 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 ISO
  13485 or ISO
  9001 and EN46001.
• Excellent computer skills with specific skills in Microsoft Office and proficiency in Solid Works.
• Compliance with relevant county, state, and Federal rules regarding vaccinations.

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.

• A competitive base salary of $145,000 - $160,000 and variable incentive plan
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but…