Failure Analysis Technician Position Available In Middlesex, Massachusetts
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Job Description
Perform inspection, testing, and documentation of returned medical devices while supporting root cause analysis and inventory management within a regulated lab environment.
Job Requirements:
High school diploma or GED Minimum of 2 years of experience in failure analysis or related technical field Experience with inspection and troubleshooting of returned products Ability to manage device inventories, including shipping and handling to other labs Capable of following detailed work instructions and documenting findings accurately Comfortable working with biohazard-classified returned products after disinfection
Preferred Skills:
Experience in the medical device industry Familiarity with
FDA 21 CFR
Part 820, EU
MDR 217/745
Knowledge of
ISO 13485, ISO 14971, IEC 60601
standards Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint) Understanding of Windows operating systems
Job Responsibilities:
Execute product inspection and testing procedures on biohazard-labeled devices Identify device failures and potential root causes, capturing supporting objective evidence Generate detailed product analysis reports Support development of tools, techniques, and processes for product analysis Coordinate and integrate data from multiple sources to support comprehensive problem analysis Maintain inventory control of devices within the lab environment and coordinate shipments to other labs as needed
Pay Details:
The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance
