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In Deutschland ist Abbott mit mehr als 3.000 Mitarbeitern in den Bereichen Forschung und Entwicklung, Logistik und Vertrieb vertreten. Neben dem deutschen Hauptsitz in Wiesbaden hat Abbott Standorte in Hannover, Neustadt am Rübenberge, Wetzlar, Eschborn, Witten, Jena und Köln. Abbott Automation Solutions GmbH in Hamburg (ehemals GLP Systems) ist nun Teil von Abbott.

Die Abbott Rapid Diagnostics Division am Standort Jena sucht ab sofort einen

Design Assurance Engineer (m/f/d)

am Standort Jena

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;

• Promotes the awareness of regulatory and customer requirements throughout the organization
• Development of effective training collateral 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
• Design Control Support for audits including Abbott Corporate Audits and external Regulatory/ Governing Body audits (e.g. FDA/ WHO).  Take the lead and front the team’s participation in audits
• Manage a team of Design Assurance Engineers as the organization grows and develops
• Ability to work is a matrix organization 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 organization.  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.

Sie finden bei uns einen spannenden Job und vielfältige Mitarbeiterangebote. Wir bieten Ihnen Entwicklungsmöglichkeiten durch ein gezieltes Talent- Management-Programm sowie eine positive, lebendige Unternehmenskultur, in der Ihre Leistung anerkannt und entsprechend vergütet wird.

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