Failure Analysis Technician I

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 for performing hands-on failure investigations for in-process, pre and post sterile devices and assisting the Engineer, Failure Analysis.

Responsibilities:

1. Perform troubleshooting and analysis of device failures according to procedures.
2. Perform product testing and escalate issues when necessary.
3. Partner with quality operations team and other team members to ensure effective inspection and testing procedures are implemented and maintained.
4. Partner with engineering groups in Engineering, Manufacturing, Lot Qual, R&D to perform root cause analysis on complex failures and trends.
5. Assist Failure Analysis Engineer in performing investigation triage and deep dive investigations to develop hypotheses for failure.
6. Collect log quality data and trend results, providing routine feedback to Failure Analysis Engineer.
7. Assist Failure Analysis Engineer in reviewing Lot Acceptance records and DHRs, creating trend charts and escalating issues when necessary.
8. Participate in troubleshooting new failure modes.
9. Assist Quality Engineers in handling CAPA, NCMR and MRB.
10. Participate in internal or external quality audits, as required.
11. Perform other duties as required.

Requirements:

1. Minimum Diploma in Engineering or Science, or a combination of education and experience. Electrical and mechanical engineering background preferred.
2. At least 3 years of hands-on failure analysis experience in PCBA, electrical and electromechanical systems, preferably in the medical device industry.
3. Experience in electrical testing and equipment maintenance.
4. Reasonable understanding of ISO13485 requirements.
5. Experience in GDP (Good Documentation Practices) & legible handwriting.
6. Proficient in Microsoft Excel, data entry, and excellent technical writing skills.
7. Must be proficient in both English and Malay languages.
8. Team player with the ability to communicate effectively with supervisors and other employees.