01.01.2024 aktualisiert
100 % verfügbar
Head of Product / Product Owner / Scrum Master / Digital Health
Simmerath, Deutschland
Weltweit
M.Sc. Information technology in healthcareSkills
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
- 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
- TBD
- TBD
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
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
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
- 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
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
- 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