Loading...
Share this Job

Sr. Design Quality Engineer

Date:  Oct 20, 2021
Location: 

Aachen, NW, DE

Abiomed ist ein innovatives Medizintechnik-Unternehmen und hat sich dem Firmenmotto „Recovering Hearts, Saving Lives“ verschrieben. Wir haben einen einzigen Leitsatz: „Patients First“. Abiomed hat seinen Firmenhauptsitz in Danvers, Massachusetts und Niederlassungen in Baltimore, Maryland, Aachen und Berlin, Deutschland sowie in Tokio, Japan. Mit 1.700 Mitarbeitern ist Abiomed eines der am schnellsten wachsenden Medizintechnik-Unternehmen weltweit. Abiomed ist ein attraktiver Arbeitgeber, der durch die Kultur der Zusammenarbeit, Leidenschaft und Einsatz für die Weiterbildung der Mitarbeiter außerordentliche Talente begeistert und bindet.

 

 

  • Support and Lead Design Assurance engineering activities in support of Abiomed’s Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting
  • Ensure that Design controls are compliant with all relevant regulations (FDA, 13485, PMDA). 
  • Ensure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
  • Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
  • Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standard
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
  • Develop statistically sound sampling plans and perform data analysis
  • Assess reliability growth strategies in both systems and software and provide input to the engineering teams

 

Job Qualifications:

  • Bachelor degree in Engineering or Sciences is required, Masters preferred
  • 5+ years of quality experience
  • Experience in the medical device industry are helpful
  • Demonstrates strong knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
  • Takes initiative and demonstrates leadership and team work

 

 

ABIOMED ist ein Arbeitgeber, der Chancengleichheit vertritt. Wir unterstützen die Chancengleichheit unserer Mitarbeiter ungeachtet der ethnischen Herkunft, der Hautfarbe, der Religion, des Geschlechts, der sexuellen Orientierung, der Geschlechtsidentität, einer Behinderung oder der Nationalität.