Senior Process Development Engineer - Pleasanton, CA

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 SolidWorks.
• 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 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.

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates, either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information, such as your full name, address, phone number, or identification documents, via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of firstname.lastname@calyxoinc.com. If you receive a request for information from any other domain, please contact us directly at info@calyxoinc.com to verify the legitimacy of the communication.

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.