Envision Diagnostics GmbH, HeidelbergManagement PositionCurrent Responsibilities:* Managing Envision Diagnostics GmbH, a wholly-owned subsidiary of Envision, Inc.* Overseeing projects for pioneering ophthalmic technology, ensuring market readiness* Providing leadership and direction to the technical team* Establishing streamlined product development lifecycle management processes and control methodologies for progress monitoring* Assisting in establishing a quality management system, aligning development processes with ISO 13485 and 21 CFR Part 820 requirementsRecent Achievements:* Finalized specifications for the minimum viable product* Completed the project plan for a groundbreaking ophthalmic medical device* Defined comprehensive design and development plans* Aligned requirements engineering processes with ISO 13485 and FDA 21 CFR 820 standards* Implemented an IEC 62304-compliant software development process using the Scrum framework* Introduced an Agile medical design and development process, ensuring compliance with ISO 13485 and FDA 21 CFR 820

Envision Diagnostics GmbH, HeidelbergLeadership RoleResponsibilities:* Spearheaded Research and Development initiatives for a pioneering medical device* Directed and coordinated five simultaneous development teams comprising software, optical, mechanical, and electronic engineersAchievements:* Established clear project milestones, crafting comprehensive milestone packages, objectives, and timelines in collaboration with respective development teams* Introduced and implemented Requirements Engineering processes, optimizing operational efficiency* Guided development teams in formulating system requirements specifications, software, and hardware module specifications for the product* Identified and delineated User Personas to refine product design and development strategies* Evaluated diverse eQMS software options available in the market, selecting the optimal fit for the company's agile medical device development requisites

Responsibilities:* Managed the research and development activities of Heidelberg's SPECTRALIS and ANTERION medical devices.* Oversaw the research and development activities for the Heidelberg Eye Explorer 2 software.* Led multiple development teams simultaneously, comprised of software, optical, mechanical, and electronic engineers.* Provided comprehensive weekly briefings to the executive management board.* Represented the company in international meetings, collaborating with eye-care professionals to assess their needs for our products.* Collaborated closely with the product management team to define stakeholder requirements for the projects.* Defined project milestones, objectives, and timelines, coordinating with the respective development teams.* Supported development teams in preparing system requirements specifications and software and hardware module specifications for the product.Achievements:* Implemented agile project management processes for the first time in the company's history.* Replaced traditional team meetings with daily stand-ups, resulting in increased team communication, motivation, and development speed.

Technical Project Leader for SPECTRALIS Software ProjectsResponsibilities:* Reviewed and managed all design review phases of the projects, ensuring alignment of processes and technical documentation with ISO 13485, IEC 62304, and 21 CFR 820 requirements.* Led the test teams for medical device verification and validation activities, ensuring strict adherence to ISO 13485, IEC 62304, and 21 CFR Part 820 requirements.Achievements:* Developed software in C++ to enhance the detection of glaucomatous damage observed with optical coherence tomography.* Defined system and module level requirements specifications, as well as created detailed design and architecture documents.* Established an academic collaboration with Heidelberg University, Department of Orthodontics and Dentofacial Orthopaedics, resulting in successful publication of project outcomes in multiple leading peer-reviewed journals.

As the Technical Project Leader for Heidelberg Eye Explorer 2 (HEYEX 2) software, my responsibilities included:- Leadership of the software projects for HEYEX 2, providing support to software engineers throughout the project lifecycle.- Definition of system and module-level requirements specifications, as well as the creation of detailed design and architecture documents.- Oversight and management of all design review phases, ensuring compliance of processes and technical documentation with ISO 13485, IEC 62304, and 21 CFR 820 requirements.- Leadership of test teams for medical device verification and validation activities, ensuring strict alignment with ISO 13485, IEC 62304, and 21 CFR 820 requirements.- Collaboration with Regulatory Experts to facilitate the preparation and introduction of HEYEX 2 into the US Market.Achievements:- Efficiently managed technical documentation, design, and development activities, resulting in successful FDA approval for HEYEX 2.

Technical Project Leader for Heidelberg Edge Perimeter (HEP) Medical DeviceResponsibilities:- Oversight of software and hardware projects for the Heidelberg Edge Perimeter (HEP), providing support to software, electronics, and optics engineers throughout the project lifecycle.- Definition of system and module-level requirements specifications, along with the creation of detailed design and architecture documents.- Review and management of all design review phases, ensuring alignment of processes and technical documentation with ISO 13485, IEC 62304, and 21 CFR 820 standards.- Leadership of test teams for medical device verification and validation activities, guaranteeing compliance with ISO 13485, IEC 62304, and 21 CFR 820 requirements.- Representation of the company in international meetings, collaborating with eye-care professionals alongside the Director of Clinical Research to analyze and identify their needs.- Collaboration with the product management team to delineate stakeholder requirements for the projects.

As a Software Engineer for the Heidelberg Edge Perimeter (HEP) medical device project, I accomplished:- Implementation of software modules for the Heidelberg Edge Perimeter medical device, enabling clinicians to detect early-stage visual field loss using Flicker-Defined Form perimetry. Additionally, it provides tools to manage disease progression in later stages using Standard Automated Perimetry (SAP). The system, designed for monitor use, demonstrates equivalent results to projection-type perimeters and boasts a compact design suitable for diverse practices.- Implementation of three Adaptive Staircase Thresholding Algorithm (ASTA) strategies and ASTA Follow-Up tests, significantly reducing follow-up examination time by utilizing data from previous scans to guide the tests.- Development of software algorithms for Functional Change Analysis (FCA), comprising a trend analysis system that monitors subtle changes in early-stage diseases via FDF perimetry. Subsequently, it manages long-term follow-up for advanced glaucoma using SAP.- Provision of comprehensive technical documentation covering HEP's system requirements, system design, software requirements specification, software architecture, and detailed design documentation, all aligned with the IEC 62304 standard.- Creation of verification and validation documentation in accordance with the IEC 62304 standard.

Software Engineer at Inta Spaceturk R&D Department* Spearheaded the development of a groundbreaking software application for satellite vehicle tracking systems, revolutionizing the way vehicles are monitored and tracked across the vast Eurasia region.* Harnessed the power of .NET Framework to meticulously craft the software, enabling real-time tracking of vehicles using high-resolution GeoEye Ikonos Satellite images with an astonishing 82 cm resolution.* Pioneered the implementation of advanced tracking algorithms, ensuring pinpoint accuracy and unwavering reliability in vehicle location identification.* Contributed significantly to Inta Spaceturk's global recognition as a leading provider of cutting-edge satellite vehicle tracking solutions.* Successfully demonstrated the software's capabilities to numerous industry experts and stakeholders, garnering widespread acclaim and driving the adoption of the innovative technology across diverse sectors.