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 itJob 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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