Manager, Failure Investigation Engineering - Pleasanton, CA

Calyxo • Pleasanton, CA

23h • $150,000 - $170,000 • Onsite

About The Position

Calyxo, Inc. is a medical device company focused on improving kidney stone treatment. The Manager, Failure Investigation Engineering leads the team responsible for investigating, analyzing, and resolving product complaints and adverse events. The role ensures timely, compliant complaint handling, identifies trends, and drives continuous improvement. It works cross-functionally with Medical Affairs, Regulatory, Operations, R&D, and Customer Service to support post-market surveillance and maintain product safety and quality.

The manager leads and develops investigators, engineers, and technicians; oversees complaint investigation operations and documentation; manages the investigations lab and its resources; and reviews investigation outcomes and reports. The position also conducts product testing and troubleshooting, supports root-cause analysis and patient-risk evaluations, identifies complaint trends, performs Lot History Reviews as needed, and contributes to broader Quality System activities. The manager serves as the subject matter expert for product investigations during audits and maintains technical documentation in accordance with applicable FDA, ISO 13485, EU MDR, PAL, and other standards.

The position is located in Pleasanton, California, with up to 10% travel. Candidates must comply with relevant county, state, and federal vaccination and health requirements and be legally authorized to work in the United States.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field, or equivalent practical experience.
• At least 8 years of experience in the medical device industry, focused on post-market surveillance, complaint handling, or quality investigations.
• Strong working knowledge of applicable medical device regulations and global quality management systems, including FDA, ISO 13485, and EU MDR.
• Demonstrated experience managing Class II or Class III medical devices.
• Proven leadership skills and a track record of developing high-performing teams.
• Excellent analytical, problem-solving, and technical writing skills.
• Proficiency in data analysis tools and methodologies for complaint trending.
• Strong verbal and written communication skills, including presenting findings to technical and non-technical audiences.
• High attention to detail and organizational ability to manage multiple priorities and projects simultaneously.
• Ability to work cross-functionally in a fast-paced environment with minimal supervision.
• Open and direct communication style and commitment to continuous improvement and operational excellence.
• Ability to lift 10 pounds and occasionally lift and carry up to 25 pounds.
• Ability to sit for up to four hours per day, including daily keyboard data entry, and to stand while working on device investigations.
• Compliance with relevant county, state, and federal vaccination and health requirements.
• Legal authorization to work in the United States.

Nice To Haves

• Experience with sterile and/or electronic medical devices.

Responsibilities

• Lead, mentor, and develop a team of investigators, engineers, and technicians, including recruiting, onboarding, training, and performance management.
• Set and manage individual and team goals aligned with departmental objectives.
• Oversee day-to-day complaint investigations to ensure timely closure and regulatory compliance.
• Ensure investigation documentation, procedures, and lab records are accurate, complete, and current.
• Train team members on complaint investigation techniques, product-specific evaluations, and regulatory requirements.
• Recommend and implement improvements to investigation procedures and processes.
• Manage the investigations lab and ensure 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 for product investigations during internal and external audits.
• Participate in the monthly Complaints Review Meeting and contribute data.
• Test and troubleshoot returned products to determine failure root causes.
• Collaborate with Quality Engineering, Manufacturing, and Product Development to verify root causes and connect them to customer-reported issues.
• Escalate new or critical failure modes and partner with Field Service, Engineering, and QA on resolution.
• Work with Clinical, Regulatory, and Medical Affairs to evaluate hazards and patient risk during investigations.
• Perform Lot History Reviews as needed.
• Analyze complaint data to identify and communicate emerging trends.
• Support Quality System activities, including 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 a collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun culture.

Benefits

• Competitive base salary of $150,000–$170,000 and a variable incentive plan.
• Stock options.
• Employee benefits package including 401(k), healthcare insurance, and paid vacation.
• Diverse work environment with experienced leaders and opportunities to shape company culture.
• Ongoing learning and dynamic challenges to support professional growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager