Process Development Engineer I

Calyxo, Inc.; Fort Erie; On-site; USD 90,000 - 105,000; Full time

Job summary

Join a forward-thinking medical device company that is revolutionizing kidney stone treatment. In this role, you will collaborate with a dynamic team to design and develop innovative manufacturing processes, ensuring product quality and regulatory compliance. Your contributions will directly impact patient care and drive the success of a mission-driven organization. With competitive compensation and a commitment to diversity and inclusion, this is an exciting opportunity for high achievers eager to grow in a supportive environment.

Benefits

Stock options

401(k)

Healthcare insurance

Paid vacation

Qualifications

• Experience in the medical device industry preferred.
• Ability to handle multiple projects and responsibilities.

Responsibilities

• Design and develop manufacturing procedures and tooling.
• Provide production line support and implement process improvements.
• Train production personnel on new products and processes.

Skills

Attention to detail

Verbal communication

Written communication

Problem-solving

Data analysis

Adaptability

Teamwork

Independence

Eagerness to learn

Education

BS in Engineering

Tools

SolidWorks

Microsoft Office

Job description

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.

In This Role, You Will:

• Complete technical projects resulting in new/improved processes for Calyxo products.


• Work closely with R&D, Quality, Manufacturing Assemblers/Technicians, and other functional areas to design and develop processes.


• 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.


• 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:

• Manager, Process Development Engineering

Requirements:

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


• Experience in medical device industry preferred.


• Work location: Pleasanton, CA


• Travel: 5%


• Full time employment


• Strong attention to detail


• Excellent verbal and written communication skills


• Eagerness to learn and accept challenges


• Ability to handle multiple projects and responsibilities and adapt to change


• Ability to solve problems and analyze data


• Ability to think and work independently and in teams


• Excellent computer skills with proficiency in Microsoft Office and 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 a compensation plan as follows:

• Competitive base salary of $90,000 - $105,000


• 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 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.