Auf einen Blick
- Aufgaben: Verwandle Daten in Antworten und Fehler in Verbesserungen für medizinische Geräte.
- Unternehmen: Dynamisches Team in Acton, MA, das FDA-zugelassene Produkte unterstützt.
- Vorteile: Wettbewerbsfähiges Gehalt, Weiterbildungsmöglichkeiten und ein unterstützendes Arbeitsumfeld.
- Weitere Informationen: Tolle Karrierechancen in einem regulierten Umfeld mit innovativen Technologien.
- Warum dieser Job: Gestalte die Qualität von medizinischen Geräten und mache einen echten Unterschied.
- Qualifikationen: Ingenieurabschluss oder gleichwertige Erfahrung, Kenntnisse in Microsoft Office erforderlich.
Das prognostizierte Gehalt liegt zwischen 59400 - 72600 CHF pro Jahr.
Failure Analysis Engineer - Contract - Acton, MA
Turn data into answers and failures into improvements as a Failure Analysis Engineer supporting FDA-approved medical devices.
Proclinical is seeking a Failure Analysis Engineer to join a dynamic team in Acton, MA.
Primary Responsibilities
The successful candidate will play a key part in ensuring the quality and reliability of FDA-approved medical devices by conducting post‑market investigations.
This hands‑on position requires strong organizational skills, attention to detail, and the ability to collaborate with cross‑functional teams to achieve quality and compliance goals.
Skills & Requirements
- Bachelor's degree in engineering or scientific discipline, or equivalent experience.
- Proficiency in Microsoft Office, particularly Excel.
- Strong electrical and mechanical background preferred.
- Experience creating and analyzing charts in Excel is a plus.
- Knowledge of Six Sigma, Lean, SPC, ASQ, or ISO process controls is advantageous.
- Prior experience in a regulated industry, such as medical devices, or working in a biohazard/lab environment is preferred.
- Effective verbal communication and excellent technical writing skills.
- Ability to generate and maintain organized and accurate records.
- Physical requirements: Sitting (70%), standing (30%), frequent lifting (up to 5 lbs), occasional handling/push‑pull (up to 50 lbs), and operating basic hand tools.
The Failure Analysis Engineer's responsibilities will be
- Conduct product testing and failure analysis to ensure compliance with quality standards.
- Collaborate with quality assurance engineers and team members to implement and maintain effective inspection and testing procedures.
- Generate, review, and maintain quality records, including training documentation, internal audits, NCRs, and CAPAs.
- Perform investigation triage and deep‑dive analyses to develop hypotheses for failures.
- 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 gathering information during FDA and ISO 13485 inspections.
- Apply Lean Six Sigma methodologies to streamline processes and improve efficiency.
- Troubleshoot new failure modes and evaluate process and engineering controls to enhance safety and performance.
- Perform other duties as assigned.
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Failure Analysis Engineer in Zug Arbeitgeber: ProClinical
Als QA Expert (Senior) in unserem globalen CMO bieten wir Ihnen die Möglichkeit, in einem dynamischen und unterstützenden Umfeld zu arbeiten, das auf Qualität und Exzellenz ausgerichtet ist. Unsere Unternehmenskultur fördert Zusammenarbeit und Innovation, während wir Ihnen zahlreiche Möglichkeiten zur beruflichen Weiterentwicklung und Schulung bieten. Zudem profitieren Sie von einem attraktiven Standort, der eine hervorragende Work-Life-Balance und Zugang zu einer lebendigen Gemeinschaft bietet.
