Failure Investigation Technician - Pleasanton, CA jobs in United States
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Calyxo, Inc. · 1 day ago

Failure Investigation Technician - Pleasanton, CA

positionPleasanton, CA
timeFull-time
remoteOnsite
seniorityMid Level
money$36/hr - $43/hr
date4+ years exp

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA, focused on improving kidney stone treatment. The Failure Investigation Technician will investigate customer complaints, facilitate investigations, and ensure compliance with FDA Quality Management System Regulations.

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H1B Sponsor Likelynote

Responsibilities

Receive, Log, and Label Incoming Complaints devices to prepare them for investigation
Maintain proper handling and storage of returned products to prevent further damage
Address and correct Incoming Complaint device discrepancies by coordinating with relevant departments
Perform decontamination on returned Complaint devices as needed in accordance with company procedures which includes safely cleaning and handling biohazardous materials and ensuring proper disposal of contaminated waste/devices
Perform detailed visual, dimensional, and functional inspections using specialized tools and equipment
Conduct and record timely investigation of returned products through troubleshooting and testing to determine root cause of reported failure mode
Partner with Product Complaint Engineering team 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
Perform Lot History Review (LHR) and record results when necessary
Summarize investigation and analysis results in and submit for appropriate approvals
Communicate potential trends associated with product complaint data to Quality
Maintain sufficient and accurate technical records per company policy
Verify calibration of tools and verify the laboratory equipment is functioning properly
Maintain the investigation area in a clean, organized, and compliant state
Monitor and replenish inventory of lab supplies (e.g., gowns, gloves, cleaning materials, tools) to ensure uninterrupted operations
Coordinate biowaste pickup and ensure proper disposal in compliance with safety and regulatory guidelines
Participate in training and development of Engineering and Laboratory personnel
Ensure work performed complies with FDA's Quality Management System Regulatory, ISO 13485, MDD, and all other applicable quality requirements
Perform other Quality System duties (e.g., CAPA, Internal Audits), as assigned

Qualification

FDA Quality Management SystemISO 13485Medical device investigationsAnalytical skillsProficient in Microsoft OfficeMeasurement tools proficiencyTechnical writingBiohazardsTroubleshootingData analysisInterpersonal communicationCritical-thinking

Required

Bachelor's degree in Science, Engineering or another technical field is a plus; High School diploma or equivalent required
At least 4 years of relevant experience with medical device investigations and complaints, or equivalent experience in a related field
Technical writing, analytical, critical-thinking, and interpersonal communication skills
Proficient in Microsoft Word, Excel, and Outlook
Proficiency with measurement tools (calipers, micrometers) and diagnostic equipment (microscopes)
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to analyze a variety of technical instructions in mathematical or diagram form and interpret various abstract and concrete variables
Legal authorization to work in the United States

Preferred

Experience with ISO13485, MDD, and FDA Quality Management System Regulations
Experience handling biohazards materials
Experience with Propel (electronic quality management system) software

Benefits

Stock options – ownership and a stake in growing a mission-driven company
Employee benefits package that includes 401(k), healthcare insurance and paid vacation

Company

Calyxo, Inc.

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Calyxo, Inc.
dateFounded in 2016
location
Pleasanton, California, USA
people-size201-500 employees
web-link
https://calyxoinc.com

H1B Sponsorship

Calyxo, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)

Funding

Current Stage
Late Stage
Total Funding
$125.44M
Key Investors
Avidity Partners
2024-12-26Series Unknown· $28.28M
2023-12-12Series D· $50M
2022-07-06Series C· $32.7M

Leadership Team

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Joseph Catanese
President & CEO
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Doug Hughes
Chief Financial Officer
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Recent News

Business Wire
Calyxo, Inc. to Present at the 44th Annual J.P. Morgan Healthcare Conference
2025-12-18
Med-Tech Insights
Calyxo announces milestone of 20,000 patients treated with CVAC System
2025-10-21
Medical Product Outsourcing
Calyxo Launches Reverse Deflection CVAC System, Shares Positive Data
2025-09-13
Company data provided by crunchbase