Insulet Corporation
Associate Failure Analysis Engineer (Onsite - Acton, MA)
Acton, Massachusetts
Sponsorship not specifiedDetected 6 days ago
ExcelProcess ImprovementFDA RegulatoryMedical DevicesWritingMicrosoft OfficeLean Manufacturing
About the role
- 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.
- Job Title: Associate Failure Analysis Engineer
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.
- Perform other duties as assigned.
Requirements
- Bachelor's Degree in an engineering or scientific discipline, or equivalent experience.
Nice to have
- Preferred Skills and Competencies:
Skills
- 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.
Benefits
- Education and Experience:
Company info
- Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
Equal opportunity
- 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.
Apply directly at Insulet Corporation →Create a free account for alerts like thisView Insulet Corporation immigration profile
This listing is sourced directly from Insulet Corporation's careers page and normalized into a canonical job model.