Supporting Customers in the following areas:* IEC 62304 compliance,* Risk Assessment from the software fault point of view,* Maintaining Traceability between deliverables,* Training personnel from IEC 62304, and basics of ISO 13485 and ISO 14971,* Communication with stakeholders.=== Projects ===Responsibilities in Project 4 (current):* Software Verification Manager (app sub-system),* Software Risk Manager (app sub-system),* leading the team of 4 Software Verification Specialists,* connecting with multiple stakeholders,* part-time: Document Control and Quality Assurance,* taking part in the Validation of the "Migration Project" (Azure DevOps).Responsibilities in Project 3:* leading the Risk Management activity as a part of the new product development,* evaluation of the firmware part of the design for software risks,* proposing adequate risk control measures (with a review of the previous design),* keeping the traceability between discovered risks, risk control measures, and verification proof,* communicating across multiple stakeholders (firmware, application/cloud, management, and regulatory teams),* mentoring the firmware team from IEC 62304 (including a review of the firmware documentation),* ISO 13485 good practice propagator and guard.Responsibilities in Project 2:* creating and leading the workshop from ISO 14971, knowledge leveling across the team,* evaluation of Software Systems connecting and controlling multiple Medical Devices, * participate in Risk Management activities for a given Software System (identification of hazards and harms, and foreseeable sequence of events that could lead to them).Responsibilities in Project 1:* training multiple groups of 10+ people (from software engineers to managers) from IEC 62304.

See Electronics Manager description

• Team Leader, manage work and priorities of up to 10 people,• IEC 62304 local expert,• managing documentation for compliation with IEC 62304,• re-design projects supervisor (hardware and software),• risk analysis for software-related topics,• technical documentation review.

• Team Leader, manage work and priorities of up to 7 people,• supervision of technical changes for compliance with UL / other certification bodies for safety and EMC standards,• obsolescence: management and prevention,• testing of new ideas, changes in software,• re-design projects supervisor (hardware and software),• architect: control system / algorithms for software implementation,• technical documentation review.

• Team Leader, manage work and priorities of up to 6 people,• conversion of business cases into technical solutions,• creating plans for research and development of products,• establishing contacts with suppliers, traders, laboratories, certification bodies; removing administrative obstacles,• identification of competencies needed to complete the project; recruitment,• architect: hardware of power electronics,• architect: control system / algorithms for software implementation (GeckoCIRCUIT),• design of PCB schematics and layouts,• active participation in launching prototypes / testing / debugging,• supervision of first prototype production batch,• certification for EMC and other standards,• development of tools for mass production (tester devices, procedures),• (episodically) software development in bash, C, java, python, Matlab / Octave / Scilab,• creating and maintaining technical documentation.

• participation in creating a prototype of a new machine,• programming of PLC controllers,• establishing contacts with sales representatives from the PLC controllers sector,• participating in the first start-up of machines.