Quality Design and Risk Manager - Medical Device Software @ BI X

le contenu du travail

BI X is Boehringer Ingelheim´s (BI) digital lab. Together with the BI businesses, BI X is developing breakthrough digital solutions in healthcare from idea to pilot. We are now expanding the horizon to a new level: improving human and animal health beyond the pill with a medical device software in wide range of applications: from SaMD solutions to embedded software and accessory products.

We are looking for talent to join us and co-create this brand-new unit at BI X that will operate across various geographies and multiple therapeutic areas.

In collaboration with a variety of experts from diverse professional backgrounds, you will drive the excellence of BI in building medical software from the spark of the first idea to a commercial product and further along the whole lifecycle.

Click here if you want to learn more: http://www.bix-digital.com

THE ROLE

As Quality Design and Risk Manager, you will be responsible for the strategic-tactical quality competence of our SaMD products. This will make you a key person for realizing and increasing the digital product portfolio at Boehringer Ingelheim. Thanks to your broad knowledge of medical device software and other pharma-related regulations, the development, manufacturing, control, and release of SaMD will run compliant with all internal and external rules and procedures. You will also participate in internal and external working groups with TA/MED/RA, Quality, Audit and Inspections and collaborate with other development departments to comply with all cGMP standards.

Desired Skills & Mindset

You are a subject matter expert in digital healthcare solutions and also possess an innovative personality with a desire to contribute to something new: setting-up BI’s first dedicated organization for end-to end development and management of SaMD and related products. You love being the linchpin in the Quality Design and Risk Management discipline, bringing your diverse medical and technical knowledge to the table. Where possible, you are passionate about using lean and agile methods to develop innovative products that are engaging, safe, and effective. You find it easy to work across functions and departments and to build both an internal and external network.

PREREQUISITES

• Master´s degree in a scientific or technical discipline (e.g., Pharmacy, Engineering, Computer Science)
• Several years of relevant working experience in the medical device or pharma industry preferably in a risk management or quality role
• English working proficiency and communication skills (verbal and written)
  

TECHNICAL EXPERTISE

• Strong expertise in the application of relevant ISO and FDA regulations (e.g. ISO 13485, 21 CFR 4 and 21 CFR 820 and emerging software as medical devices standards including China market)
• In depth knowledge with design history files, technical files and other regulatory submission relevant documentation (DMF, MAF, CTD)
  

NON-TECHNICAL COMPETENCIES

• You combine creative and analytical skills to develop innovative solutions and find efficient answers to tough challenges.
• Complex problem solving energizes you and you enjoy developing strategic-tactical solutions around our SaMD products.
• You are a networker and have an excellent understanding of building and managing relationships.
• You know how essential teamwork is but also how important it is to bring about decision as an expert, to give direction and to communicate these effectively.
  

OUR OFFER

Our office culture is casual, inclusive, fun and social, with an emphasis on education and innovation. You will work on challenging projects in an innovative state-of-the-art technological environment in small teams of highly motivated colleagues who join us from a variety of backgrounds. We work at a fast pace, yet have the freedom to try new ideas, experiment and are expected to be constantly learning and growing. There is also a strong emphasis on mentoring others in the group, enabling them to grow and learn. We will offer you exciting career prospects within a start-up-like environment, yet aligned toBoehringerIngelheim.

INTERESTED?

Send your online application with a detailed CV by TALEO.

For further information please contact our Recruiting EMEA Team, phone: +49 (0)6132 77-173173