Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Witten, Cologne and Jena. Abbott Automation Solutions in Hamburg (formerly GLP Systems) is now Abbott.

Abbott Rapid Diagnostics Division is looking for a

(Senior) Design Assurance Engineer (m/f/d)

based in Jena, Germany, or Galway, Ireland

The global Design Assurance team for IDEM, the Infectious Diseases Emerging Market Business Unit, supports R&D, Marketing, Clinical Operations, Regulatory Affairs, Quality and Manufacturing Functions based in Europe, Asia and US. The teams is responsible for Design Control throughout the lifecycle of projects, from ideation through to product launch including sustainment, for realization of our Lateral Flow Diagnostic Devices. The team supports a rapidly expanding business unit within Abbott.

To ensure we can rapidly expand our Design Assurance capability, we are recruiting a (Senior) Design Assurance Engineer (m/f/d) that will strengthen the team through implementation of best practice design controls and support the Organization as a whole to maintain those within our projects.

Main Responsibilities:

• Leads the development of the design verification and validation strategy for the project.
• Promotes the awareness of regulatory and customer requirements throughout the organization.
• Development of effective training to ensure compliance to design control policies within the Core Teams, Extended teams and relevant functions within the Business Unit.
• Provision of on-going risk management, design control, quality systems and overall design assurance expertise and leadership to the Project Core and Extended teams.
• Embed Design Assurance in all stages of the design concept and feasibility to support R&D through specification setting, test development and provision of statistical sampling to ensure robust prototypes and design at design freeze.
• Support new test development and appropriate test method validation.
• Perform technical reviews of design documentation and labelling, attend at design reviews, coordinate and facilitate completion and update of design risk management documentation and acts as independent reviewer for all design activities including design changes.
• Leads a team of Design Assurance Engineers as the team grows and develops.
• Ability to work is a matrix organisation where project deliverables are accountable to the Program/ Workstream Leader.

Your Profile:

• Primary Degree level qualification in Science, Engineering or Technology, plus 5 years of Quality Engineering/ Design Assurance work experience within a regulated environment (ISO13485/ FDA).
• Strong technical capability.  Experience within an electronic or electrical environment and knowledge of NFC/ Bluetooth would be an advantage.  
• Formal training in Medical Device Risk Management, Process Validation, Software Validation and problem Solving would be beneficial.
• Excellent data analysis skills.
• Proven ability to work well as part of a team and on own.
• Excellent communication skills to support virtual project requirements.
• Clear demonstrated experience in working in a diverse cultural environment.
• Excellent presentation skills to facilitate communication throughout the organisation.  In addition, excellent use of virtual communication technology is required for effective workshop leadership and change management.
• Travel pending company policy, global and country regulations to Asia and Europe.  

Please apply with English documents.

Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company’s success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents.

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application.
 

Discover why candidates choose a career with Abbott in Germany.

AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce.

We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.