Failure Analysis Engineer (On-site)

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.

Position Overview:
The Post Market 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.
• Partner with engineering groups in Manufacturing, Lot Qual, Lifecycle, and Systems R&D to perform root cause analysis on complex failures and trends.
• Train and mentor new hire Associate Failure Analysis Engineers.
• Approve MDR investigations prior to submission as needed.
• 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
• >1 year of direct 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
• Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred
• Preferred 2 years in a Quality related function, working with QSR and/or ISO 13485.
• Effective verbal and excellent technical writing skills.
• Excels at generating and maintaining organized and accurate records.

Physical Requirements (if applicable):          

• Sitting 70%, Standing 30%
• Frequent lifting <5lbs
• Occasional (<5% of time) handling (push/pull) up to 50lbs
• Ability to operate basic hand tools

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite  

Additional Information: