Failure Analysis Technician

2 weeks ago

Gelang Patah, Malaysia Insulet Corporation Full time

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it

Job Title: Technician, Failure Analysis Department: Quality Manager/Supervisor: Engineer, Failure Analysis Position Overview: The Technician, Failure Analysis is responsible to perform hands-on failure investigations for in-process, pre and post sterile device and assisting the Engineer, Failure Analysis. Responsibilities: - Perform troubleshooting and analysis of the device failure according to procedures. - Perform product testing and escalate issues when necessary. - Partner with quality operations team and other team members to ensure effective inspection and testing procedures are implemented and maintained. - Partner with engineering groups in Engineering, Manufacturing, Lot Qual, R&D to perform root cause analysis on complex failures and trends. - Assist Failure Analysis Engineer to perform investigation triage and deep dive investigations to develop hypothesis for failure. - Collect log quality data and trend results provide routine feedback to Failure Analysis Engineer. - Assist Failure Analysis Engineer to review Lot Acceptance records and DHRs, create trend charts and escalate issues when necessary. - Participate in trouble shoot new failure modes. - Assist Quality Engineers in handling CAPA, NCMR and MRB. - Participate in internal or external quality audits, as required. - Performs other duties as required. Requirements - Minimum Diploma in Engineering or Science, or with a combination of education and experience. Electrical and mechanical engineering background preferred. - At least 3 years of hands-on failure analysis experience in PCBA, Electrical and electromechanical systems, preferably in Medical Device industry. - Experience in electrical testing and equipment maintenance. - Reasonable understanding of ISO13485 requirements. - Experience in GDP (Good Documentation Practices) & legible handwriting - Microsoft Excel, data entry and excellent technical writing skills. - Must be proficient in both English and Malay language. - Team player and ability to communicate effectively with supervisor and other employees.

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