Manager, Failure Investigation Engineering

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 planning, assigning, and leading the team responsible for the investigation, analysis, resolution, and trending of complaints. This includes ensuring the timely processing of complaints and adverse event reporting. The Product Monitoring Manager works with cross functional groups such as Medical Affairs, Regulatory, Operations, Customer Service and R&D to perform all aspects of complaint investigations and complaint handling.

In This Role, You Will:

• Manage high-performing investigators, engineers, and technicians by recruiting, selecting, orientating, and developing team member growth.
• Lead and motivate a high-performing team by communicating job expectations, developing action plans, monitoring and appraising work performance, coaching and counseling team members.
• Complete check-ins and annual performance reviews
• Manage, create and update goals for direct reports.
• Manage daily complaint investigations to assure on time completions.
• Create and update investigation documentation and procedures.
• Train new team members on proper investigation techniques, procedures and practices.
• Train team members on new product investigations
• Recommend and implement changes in investigation processes.
• Maintain sufficient and accurate technical records in an engineering notebook per company policy.
• Manage investigations lab and assure appropriate equipment is available for thorough investigations.
• Review the accuracy of investigations and communicate changes as needed.
• Participate in Quality team audits as the investigation SME.
• Lead or Participate, generate data, and give feedback for the monthly Complaints Meeting.
• Conduct and record timely investigation of returned products through troubleshooting and testing to determine root cause of reported failure mode.
• Partner with Quality Engineering, Manufacturing Engineering, and Product Development to analyze test results to demonstrate root cause failures and linkage to customer reported symptoms.
• Escalate complaints when encountering new failure modes and partner with Engineering, Field Personnel, and Quality Assurance to investigate.
• Collaborate with Clinical, Regulatory, and Medical Affairs on hazards evaluation and potential patient risk and safety hazard investigations.
• Perform Lot History Review (LHR) and record results when necessary.
• Communicate potential trends associated with product complaint data to Quality.
• Maintain sufficient and accurate technical records per company policy.
• Participate in training and development of Engineering and Laboratory personnel.
• Ensure work performed complies with FDA's Quality System Regulatory, ISO 13485, EU MDR, PAL and all other applicable quality requirements.
• Perform other Quality System duties (e.g., CAPA, Internal Audits), as assigned.
• Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun

Who You Will Report To:

• Product Monitoring Manager

Requirements:

• Bachelor's degree in Engineering, Science, or another technical field; or equivalent practical experience
• 8+ years of experience in medical device industry, with focus on post-market surveillance or related areas
• Strong knowledge of medical device regulations and quality management systems
• Excellent analytical and problem-solving skills.
• Proficiency in data analysis tools, technical writing, and interpersonnel skills.
• Strong communication and presentation skills
• Ability to work effectively in a cross-functional team environment
• Education: Bachelor of Science in Engineering, Technical, or Life Science discipline; or equivalent experience
• Excellent level of organizational skills and ability to work on several projects simultaneously with a high attention to detail
• Open and direct communication style and a vision for continuous improvement and excellence
• Experience with Class II or III sterile devices preferred
• Experience with electronics devices
• 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
• Travel: up to 10% travel

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 a compensation plan as follows:

• Competitive base salary $150,000 - $173,000
• Stock options - ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse 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.