Staff Process Development Engineer

Summary

This position leads the development and optimization of manufacturing processes for Calyxo's medical devices, with a focus on improving efficiency, reducing variability, and ensuring regulatory compliance. Key responsibilities include designing and implementing procedures, tooling, and fixtures; supporting production operations; generating technical documentation; training personnel; and executing process and equipment validations. The role requires strong cross-functional collaboration, application of LEAN and Six Sigma methodologies, and proficiency in SolidWorks. Ideal candidates will have a BS in Engineering, over 10 years of medical device manufacturing experience, and expertise in electronics, PCBA, and catheter-based systems.

In This Role, You Will:

• 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.

• 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 SolidWorks.

• Write and execute process and equipment validations (IQ/OQ/PQ).

• Ensure product quality and support regulatory compliance.

Who You Will Report To:

• See Organizational Chart

Requirements:

• Education: BS in Engineering or a combination of relevant education and experience.

• Minimum of 10 years of experience supporting medical device manufacturing. Experience with both mechanical and electrical systems preferred.

• Work location: Pleasanton, CA

• Travel: 5%

• Full time employment

• The following skills are desired:

• Experience with electronics/PCBA assembly, troubleshooting, and failure analysis.

• Experience designing, building, and implementing manufacturing fixtures.

• Experience with catheter manufacturing processes.

• Experience in leading 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.

• 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 an attractive compensation package, which includes:

• A competitive base salary 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 prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.