Manufacturing Engineer – Capital 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 Manufacturing Engineer supports the development improvement and sustainment of manufacturing processes for CVAC 2.0 with a focus on quality efficiency and scalability. This role collaborates crossfunctionally with R&D Quality and Manufacturing teams to implement process improvements support production and transition new products and processes into manufacturing. The position also contributes to documentation validation equipment support and continuous improvement while ensuring regulatory compliance and product quality.

In This Role You Will:

• Support technical projects leading to new/improved processes for CVAC 2.0.
• Collaborate 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.
• Contribute to 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.
• Create and update high-quality manufacturing process documentation and assure that processes and documentation follow established policies and procedures.
• Apply 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.
• Support the execution of process and equipment validations (IQ/OQ/PQ).
• Coordinate with external vendors as needed.
• Perform routine equipment maintenance by following manufacturers instructions and established procedures.
• Communicate project status schedule baselines schedule issues project risks and major decisions across all company disciplines.
• Support product quality and support regulatory compliance.

Who You Will Report To:

• Principal Manufacturing Engineer

Requirements:

• Education: Bachelor of Science in Engineering or a combination of relevant education and experience
• 5 years experience supporting medical device manufacturing
• Experience with electronic components/assembly in the context of medical device capital equipment.
• Work location: Pleasanton CA
• Travel: up to 20%
• 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 working with capital equipment having field upgradable software.
• Desirable: Experience with phased medical device product development process and performing design transfer.
• Desirable: Experience designing building and implementing manufacturing fixtures and processing aids.
• 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 range of $125000 - $135000 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 onlyvalued but alsoprioritized. 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 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.

Disclaimer:

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. If you receive a request for information from any other domain please contact us directly at 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.