Manager, Failure Investigation Engineering - Pleasanton, CA
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Key details
- Location
- Pleasanton, CA, United States
- Work style
- Onsite
- Level
- Senior
- Function
- Operations & Strategy
- Focus area
- other
- Posted
- 4d ago
Skills
About the role
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 Manager, Failure Investigation Engineering is responsible 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, and compliance reporting.
- Maintain technical documentation in compliance with FDA regulations, ISO 13485, EU MDR, PAL, and other applicable standards.
- Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!
Who You Will Report To:
- Sr. Manager, Product Monitoring
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field; or equivalent practical experience.