21.10.2025 aktualisiert
Premiumkunde
100 % verfügbar(Interim) Head of Product / Senior Product Owner / Project Manager for Medical Device Development
Heidelberg, Deutschland
Weltweit
M.Sc. Information Technology in HealthcareSkills
InnovationCADKünstliche IntelligenzKrankenaktenKlinische ArbeitenKlinische PraxisComplianceKontinuierliche ÜberwachungCertified Scrum Product OwnerDicomElektronischer DatenaustauschErgonomieMedizinische VersorgungHIPAAIec 62304Interim ManagementInteroperabilitätIso 13485ISO 14971ISO / IEC 27001Machine LearningInstandhaltungÄrztliche SchweigepflichtGebrauchsinformationDatenschutzrechtSystementwicklungs-LebenszyklusQualitätsmanagementRegulatorischen AnforderungenFernüberwachungAnforderungsanalyseRisikoanalyseSoftwareentwicklungStakeholder ManagementUsability TestingWorkflowsRichtlinie für MedizinprodukteGesundheitssystemBenutzer-akzeptanzHealth Level Seven InternationalRegulatory AffairsSicherheitsbestimmungenRisikomanagement
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:
- Regulatory Compliance: A deep understanding of the regulatory landscape, including standards like ISO 13485, IEC 62304.
- Quality Management Systems (QMS): Proficiency in establishing and maintaining effective QMS to meet regulatory requirements. This includes documentation, risk management, and validation processes.
- 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.
- 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.
- 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.
- Interoperability: Familiarity with standards for data exchange and interoperability, such as HL7 and DICOM, to ensure seamless integration with other healthcare systems and devices.
- 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.
- Clinical Workflow Understanding: Insight into clinical processes and workflows to design software that integrates seamlessly into healthcare settings, improving efficiency and user adoption.
- Validation and Verification: Expertise in developing and executing validation and verification protocols to ensure the safety, efficacy, and performance of the medical device software.
- 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.
- Emerging Technologies: Keeping abreast of technological advancements, such as AI and machine learning, and their potential applications in healthcare to stay innovative and competitive.
- 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.
- 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, and compliant healthcare solutions.
Sprachen
DeutschMutterspracheEnglischgut
Projekthistorie
- Leading technical development and quality assurance activities
- Leading electronics and software development of active medical device
- Conducting supplier audits and supplier qualification
- Ensuring regulatory compliance throughout development process
- Conduct market analysis to understand customer needs, competition, and trends.
- Define the product vision, value proposition, and target markets.
- Collaborate with R&D, engineering, and design teams to define product specifications.
- Oversee prototyping, testing, and user experience design.
- Ensure product usability, safety, and efficacy through testing and validation.
- Work with regulatory affairs teams to ensure compliance with relevant standards (e.g., FDA, EU MDR).
- Prepare and oversee regulatory submissions.
- Manage risk assessments and ensure the product meets safety regulations.
- Align with manufacturing teams on production processes and quality standards.
- Collaborate with supply chain teams to ensure product availability.
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