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Letztes Update: 12.04.2024

(Interim) Head of Product / Senior Product Owner / Project Manager for Medical Device Development

Abschluss: M.Sc. Information Technology in Healthcare
Stunden-/Tagessatz: anzeigen
Sprachkenntnisse: deutsch (Muttersprache) | englisch (gut)

Schlagwörter

Medizinische Versorgung Qualitätsmanagement Risikomanagement Compliance HIPAA Datenschutzrecht Softwareentwicklung Usability Testing Sicherheitsbestimmungen Innovation + 32 weitere Schlagwörter anzeigen

Dateianlagen

CV-Jonathan-Wirtz-inkl-Projektliste_110324.pdf

Skills

As an expert in the development of medical device software I possess a multifaceted skill set and in-depth knowledge to navigate the complex and highly regulated field of healthcare technology. My key knowledge areas include:
  1. Regulatory Compliance: A deep understanding of the regulatory landscape, including standards like ISO 13485, IEC 62304. 
  2. Quality Management Systems (QMS): Proficiency in establishing and maintaining effective QMS to meet regulatory requirements. This includes documentation, risk management, and validation processes.
  3. Risk Management: Expertise in identifying, assessing, and mitigating risks associated with medical device software. Knowledge of ISO 14971 and the ability to implement risk management processes is essential.
  4. Software Development Life Cycle (SDLC): In-depth knowledge of SDLC tailored to medical device software. This includes requirements analysis, design, implementation, verification, validation, and maintenance, adhering to industry best practices.
  5. Health Information Security: Understanding and implementing robust security measures to protect patient data and ensure compliance with standards like ISO 27001. This is especially critical given the sensitivity of health-related information.
  6. Interoperability: Familiarity with standards for data exchange and interoperability, such as HL7 and DICOM, to ensure seamless integration with other healthcare systems and devices.
  7. Usability Engineering: Knowledge of human factors engineering and usability standards (e.g., IEC 62366) to create software interfaces that are intuitive and user-friendly for healthcare professionals and patients.
  8. Clinical Workflow Understanding: Insight into clinical processes and workflows to design software that integrates seamlessly into healthcare settings, improving efficiency and user adoption.
  9. Validation and Verification: Expertise in developing and executing validation and verification protocols to ensure the safety, efficacy, and performance of the medical device software.
  10. Compliance with Privacy Laws: Awareness of and adherence to privacy laws such as HIPAA (Health Insurance Portability and Accountability Act) to protect patient confidentiality and privacy.
  11. Emerging Technologies: Keeping abreast of technological advancements, such as AI and machine learning, and their potential applications in healthcare to stay innovative and competitive.
  12. Collaboration with Cross-functional Teams: Effective communication and collaboration with regulatory affairs, quality assurance, hardware engineers, clinicians, and other stakeholders involved in the development process.
  13. Post-Market Surveillance: Understanding the importance of continuous monitoring, feedback, and updates post-launch to address issues, improve performance, and ensure ongoing compliance.
Having expertise in these areas equips me as an professional to navigate the intricate landscape of medical device software development, contributing to the creation of safe, effective, and compliant healthcare solutions.

Projekthistorie

12/2022 - bis jetzt
Director Medical Device Development (Authorized Representative
TWT Digital Health (Pharma und Medizintechnik, 10-50 Mitarbeiter)
Responsibilities
  • Main responsible for success software development program Health / Medical Devices
  • Ensure 
    • efficiency, 
    • regulatory compliance and
    • budget overall projects within the program
  • Leading steering committees with key accounts and escalate project related issues
  • Working closely with top management to define vision and strategy for the health entity 
  • Taking ownership of presales activities and perform customer workshops
  • Generate new businesses with existing and new accounts
  • Establish scalable agile procedures within the team
  • Leading a team of 15 people all over europe
08/2020 - 11/2022
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 high-value feature

    • Report development output to top management and key accounts

    • Collaborate with development, regulatory, quality to organize market access (medical device) within Europe

  • Strategy:

    • Implement product / portfolio vision, strategy and discuss with stakeholders

    • Define a suitable resource planning which is aligned with the product portfolio

    • Budget planning 

 

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
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
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 13485
- 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

Zertifikate

UXQB - Certified Professional for Usability and User Experience
iSQI
2017

Reisebereitschaft

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Profilbild von Anonymes Profil, (Interim) Head of Product / Senior Product Owner / Project Manager for Medical Device Development (Interim) Head of Product / Senior Product Owner / Project Manager for Medical Device Development
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