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Manager, Failure Investigation Engineering - Pleasanton, CA

Calyxo

Manager, Failure Investigation

About Calyxo

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.

Responsibilities

  • Th
  • e
  • 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.
  • 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.

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.
  • 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!
  • Sr. Manager, Product Monitoring

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related technical field;
  • or equivalent practical experience.
  • Minimum of 8 years of experience in the medical device industry, with a focus on post-market surveillance, complaint handling, or quality investigations.
  • Strong working knowledge of applicable medical device regulations and global quality management systems (FDA, ISO 13485, EU MDR, etc.).
  • Demonstrated experience managing Class II or III medical devices; experience with sterile and/or electronic devices preferred.
  • Proven leadership skills with

a track record

  • of developing high-performing teams.
  • Excellent analytical, problem-solving, and technical writing skills.
  • in data analysis tools and methodologies for complaint trending.
  • Strong verbal and written communication skills with the ability to present findings to technical and non-technical audiences.
  • High attention to detail and organizational ability to manage multiple priorities and projects simultaneously.
  • Comfortable working in a cross-functional, fast-paced environment with minimal supervision.
  • Open, direct communicator committed to continuous improvement and operational excellence.
  • Must be able to lift 10 p