Design Quality Engineer I, Lifecycle

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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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 .

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 were 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 thats 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 3000 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 roles emphasis will be in support of Abiomeds existing single-use heart pumps.

Principle Duties and Responsibilities:

• Support Design Assurance engineering activities in support of Abiomeds 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 FMEAs 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 (CRs) and support the Non-Conformance (NCs) 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.

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