26.10.2026 aktualisiert
nicht verfügbar
info: nicht verfügbar bis 31.12.2026
Product Manager / Product Owner
München, Deutschland
Deutschland +2
Dipl.-Inform., Dr. rer. nat., MBAinfo: Deutschland, Österreich, Schweiz
Skills
Agile MethodologieAmazon Web ServicesAndroidMicrosoft AzureSaasCloud ComputingIphone AppsIso 13485ISO 14971Produkt ManagementScrumSalesforce.ComBerichterstattung über MedizinprodukteBackendGXP
Product Management, Product Owner, Scrum, Cloud, Salesforce Service Cloud, Android, Azure, backend, Android App / DiGA, SaaS, Agile Methodologies, Software as a medical device, GxP, ISO 14971, ISO 13485, MDR
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2022
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Project: Provide IT/OT infrastructure for a new GMP and nonGMP site for the development and manufacturing of new Gene Therapeutics
As Business Analyst:
- Developed strategy and implemented method for digitalization and automation of process transfer across several IT systems: Emerson Fluxa PKM, Rockwell Pharmasuite, SAP S4/Hana, Simatic PCS7.
- Site implementation lead for Emerson Fluxa PKM at Penzberg Gene Therapy Development Center.
- Managed E2E process transfer for 3 new drugs in phase I, phase III and pre-tox fully with digital systems.
- Authored SOPs for GMP relevant processes.
As Scrum Master: Guided the team to develop a “GMP ready anytime” agile process which enabled them to deliver new requirements and changes to GMP relevant digital manufacturing systems in small increments while adhering to regulatory requirements.
Project: Lab Digitalization for a manufacturer of Diagnostics devives
- Managed subject matter experts and stakeholders from Roche Diagnostics Corelab.
- Analyzed their requirements and harmonized them with similar requirements from other Roche networks.
- Designed a solution that enforces GxP compliant business processes.
- Wrote user stories and refined them with the dev team.
- Improved agile processes for developing GxP validated applications.
GmbH, Pullach
Responsible for HCSG's e-health products:
* Design and development of a new telemonitoring SW
product for cardiologists (Salesforce Service Cloud).
* Timely delivery of an innovative SW product for the
telemedical management of congestive heart failure for a
trial with Deutsches Herzzentrum (Android app / voice
assistant with Azure backend).
* Business case and evaluation of a new SW product for
COPD patients (Android App / DiGA).
* Mentoring of HCSG's product owners.
Regulatory:
* Re-design of HCSG's risk management according to ISO
14971.
* Managing the certification of HCSG's telemedical
platform as medical device (MD) class IIa (MDR).
Responsible for HCSG's e-health products:
* Design and development of a new telemonitoring SW
product for cardiologists (Salesforce Service Cloud).
* Timely delivery of an innovative SW product for the
telemedical management of congestive heart failure for a
trial with Deutsches Herzzentrum (Android app / voice
assistant with Azure backend).
* Business case and evaluation of a new SW product for
COPD patients (Android App / DiGA).
* Mentoring of HCSG's product owners.
Regulatory:
* Re-design of HCSG's risk management according to ISO
14971.
* Managing the certification of HCSG's telemedical
platform as medical device (MD) class IIa (MDR).
Zertifikate
Professional Scrum Product Owner II
Scrum.org2023
Professional Scrum Master I
Scrum.org2023
CSM
Scrum Alliance2015
CSPO
Scrum Alliance2013
PRINCE 2 Practitioner
APMG-International2013