Sr. Failure Investigation Engineer - 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.

In This Role, You Will:

The Senior Failure Investigation Engineer is responsible for investigating returned product, establishing documented routine investigation processes, assessing existing and potential failures, and working with the Product Monitoring team to document investigation finding as part of the complaints process.  This role will assist in driving product quality as part of continuous improvement, feeding investigation results back to manufacturing and R&D.

Complaint Investigation Process

• Perform failure investigations on returned product using lab equipment such as flow testers,  boroscopes, cameras, and hand tooling in combination with review of design documentation, system log data, and software tools.
• Establish documented routine complaint investigation processes and procedures for returned devices.
• Establish workflow in the complaint investigation lab and lead prioritization of device investigations.
• Coordinate device returns with Customer Service and Material Handling functions.
• Perform disinfection, processing, root cause analysis, disposition and tracking of returned devices.
• Ensure complaint investigation files are completed in a timely manner, accurately reflecting corresponding complaint investigation activities.
• Present failure investigation data to R&D and other cross-functional teams in order to to reduce occurrence rates and enhance ongoing field training.
• Work with the Product Monitoring team to resolve questions around potentially reportable failures.
• Work with Product Monitoring team on assessing failure trends and statistics.
• Work to develop new failure codes and bucketing of failure modes as needed.
• Implement corrective and preventive actions (CAPAs) as needed
• Assist in Quality System audits with various government agencies, private companies, and consultants (such as CA FDB, US FDA, etc.), and respond to any action promptly.
• Perform other duties as assigned.

Who You Will Report To:

• Sr. Director, Quality

Requirements:

• Bachelor's degree in Biomedical Engineering, Life Sciences, or related field; advanced degree preferred
• 7+ years of experience in medical device industry, with focus on product failure investigations or related areas
• Experience with electrical, mechanical, and software medical device products
• Strong knowledge of medical device regulations and quality management systems
• Excellent analytical and problem-solving skills
• Proficiency in data analysis tools and statistical methods
• Strong communication and presentation skills
• Ability to work effectively in a cross-functional team environment
• Excellent level of organizational skills and ability to work on several projects simultaneously with a high attention to detail
• Open and direct communication style and a vision for continuous improvement and excellence
• Experience with Class II or III sterile devices preferred
• Must be able to lift 10 pounds and occasionally lift and carry up to 25 pounts, sit for up to 8 hours/day, including daily keyboard data entry.
• Compliance with relevant county, state, and Federal rules regarding vaccinations
• Work location: Pleasanton, CA
• Travel: up to 5% travel

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 salary range of $135,000 - $150,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

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.