Design Quality Engineer I, Lifecycle

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function
Quality
Job Sub Function
R&D/Scientific Quality
Job Category
Professional
All Job Posting Locations:
Aachen, North Rhine-Westphalia, Germany
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at Cardiovascular
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Abiomed is an innovative medical device company with an inspiring mission of “Patients First” and a unique guiding principle of “Recover Hearts.” Saving Lives.” With more than 3,000 employees, Abiomed is one of the fastest growing medical technology companies in the world, with headquarters in Danvers, USA, and locations in Aachen, Germany, Tokyo, Japan and Singapore. Abiomed is part of Johnson & Johnson MedTech.
Abiomed is an employer offering attractive working conditions and a rewarding corporate culture focused on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.
Job Responsibilities
The Design Quality Engineer will have the opportunity to perform various Design Quality Engineering functions supporting continuous improvement and innovation of marketed products! Activities will include risk management, design verification, design validation, design assurance activities, as well as manufacturing process development support statistical analysis and more! This role’s emphasis will be in support of Abiomed’s existing single-use heart pumps.
Principle Duties And Responsibilities

• Support Design Assurance engineering activities in support of Abiomed’s 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.
• Navigate existing FMEA’s and Hazard Analysis in support of sustaining and lifecycle activities.
• 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 Requests (CR’s) and support the Non-Conformance (NC’s) process as necessary.
• Act as an effective team member in the execution of Quality functions in compliance with FDA QMSR (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.
• Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
• Develop statistically sound sampling plans and perform data analysis.
• Be a voice of quality and ensure compliance to internal & external quality standards.
• Bring ideas that challenges current thinking.
  

Job Qualifications

• Bachelor degree in Engineering or Sciences is required, Masters desired
• 0 - 2 years of quality experience
• Experience in the medical device industry as well as cardiovascular devices highly preferred
• Demonstrates knowledge of quality engineering policies, principles and best practices and FDA/ISO requirements
• Takes initiative and works well in a team environment
  

The anticipated base pay range for this position is 51.200 to 80.845 EUR.
Required Skills
Preferred Skills:
Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering and Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing

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