Profilbild von Anonymes Profil, Head of Product / Product Owner / Scrum Master / Digital Health
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Letztes Update: 01.01.2024

Head of Product / Product Owner / Scrum Master / Digital Health

Abschluss: M.Sc. Information technology in healthcare
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (verhandlungssicher)

Dateianlagen

cv-jonathan-wirtz.pdf

Skills

Head of Product 
  • Establish agile development procedures in medical device development regulatory framework
    • Align risk management, usability engineering and market access procedures with development
  • Increase productivity of development teams, without braking architectural constraints
  • Increase accountablilty of each teammeber to ensure employee satisfaction
  • Organize suitable product vision and strategy workshops
  • Establish Planning frameworks to ensure all stakeholders are updated and satisfied 
Product Owner
  • Organize Product backlog and their items according to product strategy 
  • Work closely with product manager / requirements engineer / developers / QA to ensure backlog items are understood and accepted
  • Perform refinements with the developers to ensure proper estimations
  • Priotize with stakeholders existing backlog items and perform sprint planning aligned with Scrum Master
  • Present sprint output to stakeholders in sprint review sessions
Requirements Engineer
  • TBD
SCRUM Master
  • TBD

Projekthistorie

08/2020 - bis jetzt
Head of Product
Clinomic GmbH (Pharma und Medizintechnik, 50-250 Mitarbeiter)

Responsibilities

 

  • Operation:
    • Main responsible for development of Mona and all other products at clinomic
    • Organize SCRUM Teams, product owners and product managers to maximize value of the product portfolio
    • Identify and transfer user needs into highvalue feature
    • Report development output to top management and key accounts
    • Collaborate with development, regulatory, quality to organize market access (medical device) within Europe
    • Control Budget and KPIs related to product and development
    • Collaborate with customer solutions to implement the products in the hospital environments as intended
  • Strategy:
    • Implement product / portfolio vision, strategy and discuss with stakeholders
    • Define a suitable resource planning which is aligned with the product portfolio

 

Achieved objectives

 

  • Placed Mona on the market as medical device
  • Hired, implemented and lead a team of 40 people (Product owner, developer, quality manager, product manager, regulatory affairs manager, software tester)
  • Implement a working quality / information security management system certified to ISO 13485 / ISO 27001
  • Established departments and organized structures for quality / Information security / regulatory / product management / Software & Hardware development

08/2019 - 07/2020
Head of Quality Management
KAIROS GmbH (Pharma und Medizintechnik, 10-50 Mitarbeiter)

Responsibilities

- Management and optimization of the QM system according
to ISO 13485
- Fulfillment of reporting obligations and communication with
authorities
- Preparation, coordination and review of technical
documentation
- Project manager for software validation in the GxP
environment
- Leading a team of 4 people

Achieved objectives

- Implement a working quality management system certified to
ISO 13485 / ISO 9001
- Prepare CentraXX for the market approval as medical device
- Supported 10 costumers in validating their trial environment, to
fulfill regulatory requirements

08/2016 - 07/2019
Consultant for Quality Management and Regulatory Affairs (Medical Devices)
Johner Institut GmbH (Pharma und Medizintechnik, 50-250 Mitarbeiter)

Responsibilities

- Strategic consulting for management teams of startups / SMEs
/ huge enterprises in placing their medical devices on the
market
- Support customers in operations by implementing
- Software life cycle processes according to IEC 62304
- Risk management according to ISO 14971
- Quality management systems according to ISO 13845
- External quality management representative for entire
organizations
- Carry out internal audits according to ISO 19011 for customers
- Perform, consult, support computerized system validation
according to ISO 13485, CFR Part 820 and GAMP5

Achieved Objectives

- Supported more than 70 Costumers in getting market
approval, complaint procedures or passed audits
- Helped the company to grow from <10 up to 60 people

05/2015 - 07/2016
Software Developer / Project Manager for interoperability
LOWTeq GmbH (Pharma und Medizintechnik, 10-50 Mitarbeiter)

Responsibilities

- Development of interfaces between an information system
used on intensive care units and
- Hospital information systems, laboratory information
systems, archives
- Vital signs monitors, ventilators,
- implemented in Java / JavaScript (HL7, XML)




- Integration & support of these interfaces
- IT - Project Management - Integration of information systems
into existing hospital infrastructure

Achieved Objectives

- Established working interfaces between completely
independent medical devices
- Optimized peri operative workflows for at least 20 hospitals

Reisebereitschaft

Weltweit verfügbar
  • Innerhalb
    • DACH-Raum maximal 1 Tag die Woche vor Ort 
    • NRW täglich vor Ort möglich
  • Hybrid modelle bevorzugt
  • Vorlaufzeit derzeit 1 - 3 Monate
Profilbild von Anonymes Profil, Head of Product / Product Owner / Scrum Master / Digital Health Head of Product / Product Owner / Scrum Master / Digital Health
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