Head of Failure Investigation Engineering

Calyxo, Inc.; Pleasanton (CA); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Competitive base salary

Stock options

401(k), healthcare, and paid vacation

Job summary

Calyxo, Inc. is seeking a Manager of Failure Investigation Engineering in Pleasanton, CA, to lead a cross-functional team focused on investigating complaints and adverse events.

The role ensures timely, compliant handling and drives continuous improvement across QA and regulatory interfaces. You will manage investigations, mentor engineers, and coordinate with Medical Affairs, Regulatory, Operations, R&D, and Customer Service to support post-market surveillance and product safety.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• Minimum of 8 years of experience in the medical device industry, focusing 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 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.

Responsibilities

• Lead, mentor, and develop a team of investigators, engineers, and technicians; recruit, onboard, train, and manage performance.
• Set and manage individual and team goals aligned with departmental objectives.
• Oversee day-to-day operations of complaint investigations for timely closure and regulatory compliance.
• Ensure investigation documentation, procedures, and lab records are accurate and up to date.
• Train team members on complaint investigation techniques and regulatory requirements.
• Drive continuous improvement by updating investigation procedures and processes.
• Manage the investigations lab with appropriate tools and resources.
• Review and approve investigation outcomes and reports for accuracy.
• Serve as SME for product investigations during audits.
• Participate in monthly Complaints Review Meetings.
• Conduct thorough testing and troubleshooting of returned products to identify root causes.
• Collaborate with Q.E., Manufacturing, and Product Development to verify root causes.
• Escalate new or critical failure modes and coordinate with Field Service, Engineering, and QA for resolution.
• Work with Clinical, Regulatory, and Medical Affairs to evaluate hazards and patient risk.
• Perform Lot History Reviews as needed.
• Identify emerging trends from complaint data analysis.
• Support CAPA investigations, internal audits, and compliance reporting.

Skills

Leadership

Data analysis

Analytical thinking

Technical writing

Cross-functional collaboration

Problem solving

Verbal communication

Education

Bachelor’s degree in Engineering, Life Sciences, or related technical field

Job description

Calyxo, Inc. is seeking a Manager of Failure Investigation Engineering in Pleasanton, CA, to lead a cross-functional team focused on investigating complaints and adverse events.

The role ensures timely, compliant handling and drives continuous improvement across QA and regulatory interfaces. You will manage investigations, mentor engineers, and coordinate with Medical Affairs, Regulatory, Operations, R&D, and Customer Service to support post-market surveillance and product safety.