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.
The Senior Manufacturing Engineer will work cross-functionally and with suppliers to ensure the successful scaling and sustained success of our internal and external medical device manufacturing processes.
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 production line support including 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 closely with R&D, Quality, and other functional areas to design and develop processes to optimize robustness and flow, reduce costs and variability, and improve capability.
- Work with external vendors as needed.
- 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 of Manufacturing Operations
Requirements:
Must Have:
- Education: Bachelor of Science in Engineering or a combination of relevant education and experience.
- Minimum 8 years of experience extensively supporting medical device manufacturing.
- Proven experience as a technical contributor with exceptional communication skills.
- Experience in leading highly technical projects in a cross-functional environment.
- Experience working with catheters.
- Experience with machining, prototyping, and hands-on skills.
- Experience designing, building, and implementing manufacturing fixtures.
- Excellent verbal, visual, and written communication skills with the ability to represent the group and bring people together cross-functionally.
- Ability to dig into the details, present data and proposals, and tailor complexity to separate groups.
- Keen sense of urgency, willingness to be in the trenches for line support, and great rapport with assemblers.
- Work collaboratively within the team and serve as a thought partner.
- Working knowledge of Design Control and cGMP requirements for medical device manufacturing and the regulatory approval process.
- Excellent computer skills with specific skills in Microsoft Office and proficiency in SolidWorks.
- Compliance with relevant county, state, and Federal rules regarding vaccinations.
Preferred:
- Experience with electronic components/assembly in the context of medical device capital equipment.
Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also 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.
Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics
Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
