Bernhard Hörmann

Former DESIGN RESPONSIBLE / PRODUCT OWNER with 4+ years at a leading company for allergy and autoimmune diagnostics.

I thrive in CHALLENGING PROJECTS that help to:

• Perform design changes

• Design regulation-ready diagnostic or medical products

• Maintain/utilize a Quality Management System according to ISO13485.

• Perform thorough Risk Assessments and (p)FMEAs according to ISO14971.

• Help customers to analyze and visualize large datasets in R and Python.

• Maintain conformity of the IVDR/MDR Technical Documentation.

• Help to implement newest CLSI guidelines into internal SOPs.

• Write state-of-the art drafts for FDA communication (e.g. pre-subs).

Exemplary PROJECT ACTIVITIES:

📌 I led CAPA activities from start to finish, including collection of evidence from complaints, on-site visits at customers, identificiation of possible countermeasures internally and with suppliers, experiments to determine their efficacy, Change process initiation, and market analysis thereafter.

📌 I established R- and Python-based scripts for analysis of large internal studies, external real-world data from log-files or data from collaborating clinics and provided concise visualization thereof to higher management. Exemplary tools used included Git for documentation, tidyverse for data handling, ggplot2, Shiny, and Streamlit for graphs.

📌 I wrote clear and concise V&V study descriptions for an FDA Presub and discussed it with FDA representatives in a telephone conference.

📌 I led several activities to handle shortages and or non-conformities for raw materials. Together with the team I carried out risk assessments, identified and investigated alternative materials and led the change process that guaranteed steady supply.

📌 I oversaw changes to the production process of existing products, for example the outsourcing of a filling process from internal to an external service provider.