Job Summary

The Associate Failure Analysis Engineer plays an integral role in Insulet’s Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals. 



Position Overview:
The Associate Failure Analysis Engineer plays an integral role in Insulet’s Quality Department as a hands-on engineering role conducting post market investigations of FDA approved medical devices. The position requires strong organization skills, attention to detail, ability to work in cross functional teams, and drive to accomplish departmental and company goals.

Responsibilities:

Perform moderately complex tasks to ensure compliance with quality standards.
Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.
Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.
Perform product testing and failure analysis.
Review Lot Acceptance records and DHRs, create trend charts.
Perform investigation triage and deep dive investigations to develop hypothesis for failure.
Collect log quality data and trend results.
Accountability for quality investigation and root cause analysis.
Assist in gathering information during FDA and ISO 13485 inspections.
Evaluate process flow by applying Lean Six Sigma methodology to streamline.
Trouble shoot new failure modes.
Evaluate process and engineering controls to improve safety and efficiency.
Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

Bachelor’s Degree in an engineering or scientific discipline , or equivalent experience.

Preferred Skills and Competencies:

Computer proficiency in MS office (specifically Excel)
Electrical and mechanical background strongly preferred
Experience creating and analyzing charts in MS Excel a plus
Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus

Job Summary

Responsibilities:

Perform moderately complex tasks to ensure compliance with quality standards.
Partner with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained.
Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA.
Perform product testing and failure analysis.
Review Lot Acceptance records and DHRs, create trend charts.
Perform investigation triage and deep dive investigations to develop hypothesis for failure.
Collect log quality data and trend results.
Accountability for quality investigation and root cause analysis.
Assist in gathering information during FDA and ISO 13485 inspections.
Evaluate process flow by applying Lean Six Sigma methodology to streamline.
Trouble shoot new failure modes.
Evaluate process and engineering controls to improve safety and efficiency.
Perform other duties as assigned.

Education and Experience:

Minimum Requirements:

Bachelor’s Degree in an engineering or scientific discipline , or equivalent experience.

Preferred Skills and Competencies:

Computer proficiency in MS office (specifically Excel)
Electrical and mechanical background strongly preferred
Experience creating and analyzing charts in MS Excel a plus
Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus

Associate Failure Analysis Engineer

Associate Failure Analysis Engineer

Insulet Corporation

Insulet Corporation

Benefits

Insulet Corporation