Medical Device Failure Analysis Engineer

Proclinical; Acton (MA); Presencial; USD 85.000 - 115.000; Jornada completa

Descripción de la vacante

Proclinical is seeking a Failure Analysis Engineer to join a dynamic team in Acton, MA, supporting FDA-approved medical devices. This contract role focuses on turning data into insights by performing post-market investigations and applying Lean Six Sigma methodologies.

The successful candidate will conduct testing, lead root-cause analyses, maintain quality records, and collaborate with QA engineers to ensure compliance with quality standards and regulatory inspections.

Formación

• Bachelor's degree in engineering or scientific discipline or equivalent experience.
• Proficiency with Microsoft Excel.
• Strong electrical and mechanical background preferred.
• Experience creating and analyzing charts in Excel.
• Knowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controls beneficial.
• Experience in a regulated industry (medical devices) or biohazard/lab environment preferred.
• Excellent verbal communication and technical writing; strong record-keeping.
• Ability to generate and maintain organized records.

Responsabilidades

• Conduct product testing and failure analysis to ensure quality standards.
• Collaborate with QA engineers to implement inspection and testing procedures.
• Generate and maintain quality records including training docs, audits, NCRs, CAPAs.
• Perform investigation triage and deep-dive analyses to develop failure hypotheses.
• Review Lot Acceptance records and Device History Records (DHRs) and create trend charts.
• Collect, log, and analyze quality data to identify trends and drive improvements.
• Lead quality investigations and root-cause analyses.
• Assist in FDA and ISO 13485 inspections.
• Apply Lean Six Sigma methodologies to streamline processes and improve efficiency.
• Troubleshoot new failure modes and evaluate processes to enhance safety and performance.

Conocimientos

Excel

Electrical background

Mechanical background

Technical writing

Verbal communication

Record keeping

Lean Six Sigma

ISO processes

Regulated industry experience

Educación

Bachelor's degree in engineering or scientific discipline

Descripción del empleo

Proclinical is seeking a Failure Analysis Engineer to join a dynamic team in Acton, MA, supporting FDA-approved medical devices. This contract role focuses on turning data into insights by performing post-market investigations and applying Lean Six Sigma methodologies.

The successful candidate will conduct testing, lead root-cause analyses, maintain quality records, and collaborate with QA engineers to ensure compliance with quality standards and regulatory inspections.