Design Quality Engineer I, Lifecycle

Abiomed

Aachen, North Rhine-Westphalia, Germany
Base: 51.200 to 80.845 eur; bonus/equity: not spec...
Not specified
Risk management
Design verification and validation
Fda qmsr and iso 13485 compliance
Abiomed is seeking a Design Quality Engineer I to support the continuous improvement and innovation of their cardiovascular medical devices, particularly single-use heart pumps. The role emphasizes design quality engineering functions including risk management, design validation, and compliance with regulatory standards

Job Summary

  • The Design Quality Engineer will perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products, including risk management, design verification, design validation, and design assurance activities.
  • This role's emphasis will be in support of Abiomed’s existing single-use heart pumps, ensuring compliance with FDA QMSR, ISO 13485, and other national and international quality and regulatory requirements.
  • Johnson & Johnson provides an inclusive work environment where each person is considered as an individual, respecting diversity and dignity, and recognizing employee merit.

Matching Summary

Match Score: 85

Abiomed is seeking a Design Quality Engineer I to support the continuous improvement and innovation of their cardiovascular medical devices, particularly single-use heart pumps. The role emphasizes design quality engineering functions including risk management, design validation, and compliance with regulatory standards.

Salary

Base: 51.200 to 80.845 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Risk management
  • Design verification and validation
  • FDA QMSR and ISO 13485 compliance
  • Statistical data analysis
  • Support single-use heart pumps

Nice-to-have

  • Challenging current thinking
  • Continuous improvement
  • Inclusive work environment
  • Voice of quality

Key Requirements

  • Bachelor degree in Engineering or Sciences
  • 0 - 2 years of quality experience
  • Medical device industry experience preferred
  • Cardiovascular devices experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter