Associate Failure Analysis Engineer; Onsite - Acton, MA

Job Summary

Job Title:

Associate Failure Analysis Engineer Department: 8610 - QA Post Market Quality AssuranceFLSA Status:
Non-Exempt 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.

• 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.
• Troubleshoot new failure modes.
• Evaluate process and engineering controls to improve safety and efficiency.li>
• Perform other duties as assigned.

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.
• 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.

Sitting 70%, standing 30%. Frequent lifting occasional. Ability to operate basic hand tools.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)