Manager, Failure Investigation Engineering - Pleasanton, CA

The posting, as Calyxo wrote it

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

Th e Manager, Failure Investigation Engineering is r esponsible for leading the team that investigates, analyzes, and resolves product complaints and adverse events. This role ensures timely and compliant complaint handling while identifying trends and driving continuous improvement. The Manager works cross-functionally with Medical Affairs, Regulatory, Operations, R&D, and Customer Service to support post-market surveillance activities and maintain product safety and quality.

In This Role, You Will

• Lead, mentor, and develop a team of investigators, engineers, and technicians by recruiting, onboarding, training, and managing performance through regular check-ins and annual reviews.
• Set and manage individual and team goals aligned with departmental objectives .
• Oversee the day-to-day operations of complaint investigations to ensure timely closure and regulatory compliance.
• Ensure investigation documentation, procedures, and lab records are accurate , complete, and up to date per company policy.
• Train team members on complaint investigation techniques, product-specific evaluations, and regulatory requirements.
• Drive continuous improvement by recommending and implementing changes to investigation procedures and processes.
• Manage the investigations lab, ensuring appropriate tools, test equipment, and resources are available and functional.
• Review and approve investigation outcomes and reports for accuracy, completeness, and clarity.
• Serve as the Subject Matter Expert (SME) for product investigations during internal and external audits.
• Participate in and contribute data to the monthly Complaints Review Meeting.
• Conduct thorough testing and troubleshooting of returned products to determine root cause of failures.
• Collaborate with Quality Engineering, Manufacturing, and Product Development teams to verify root causes and link to customer-reported issues.
• Escalate new or critical failure modes and partner with Field Service, Engineering, and QA for resolution.
• Work with Clinical, Regulatory, and Medical Affairs to evaluate hazards and patient risk during investigations.
• Perform Lot History Reviews (LHRs) as needed.
• Identify and communicate emerging trends based on complaint data analysis.
• Support broader Quality System activities, such as CAPA investigations, internal audits,

[…]
verse 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.

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 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.