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.
- 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.
- Proficiency 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 pounds and occasionally lift and carry up to 25 pounts, sit for up to 4 hours/day, including daily keyboard data entry, and stand while working on device investigations
- Compliance with relevant county, state, and Federal rules regarding vaccinations
- Work location: Pleasanton, CA
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 an attractive compensation package, which includes:
- A competitive base salary range of $150,000 - $170,000 and variable incentive plan
- Stock options - ownership and a stake in growing a mission-driven company
- Employee benefits package that includes 401(k), healthcare insurance and paid vacation
