Failure Investigation Engineering Manager – Medical Devices

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

Benefits offered by this job

Stock options

401(k)

Healthcare insurance

Paid vacation

Job summary

Calyxo, Inc. in Pleasanton, CA, seeks a Manager, Failure Investigation Engineering to lead a team of investigators and engineers responsible for post-market surveillance and root-cause analysis of complaints.

You will partner across Medical Affairs, Regulatory, Operations, R&D and Customer Service to ensure timely, compliant investigations, maintain documentation per FDA/ISO standards, and drive continuous improvement in investigation procedures.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field; or equivalent practical experience.
• Minimum of 8 years in the medical device industry, with 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.).
• Proven leadership skills with a track record of developing high-performing teams.
• Excellent analytical, problem-solving, and technical writing skills.

Responsibilities

• 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.
• 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.

Skills

Leadership

Analytical

Regulatory knowledge

Technical writing

Cross-functional

Education

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

Job description

Calyxo, Inc. in Pleasanton, CA, seeks a Manager, Failure Investigation Engineering to lead a team of investigators and engineers responsible for post-market surveillance and root-cause analysis of complaints.

You will partner across Medical Affairs, Regulatory, Operations, R&D and Customer Service to ensure timely, compliant investigations, maintain documentation per FDA/ISO standards, and drive continuous improvement in investigation procedures.