Sebastian Jacota
Senior Medical Device Software Engineer | Regulatory Compliance
Salary / Daily rate
Bucharest, Romania
Freelance
Can come onsite
Skills
Languages
About me
Intro
Medical device consultant with 13+ years of expertise in connected devices and regulatory compliance. Led development of Class II/III medical devices and implemented Thread/Matter solutions for IoT platforms. Specialized in reducing regulatory costs while ensuring IEC 62304 compliance for medical device R&D.
Work experience
Engineering Manager - Device Platform & CI/CD
tado°
May 2022 - Present
4 years 6 months
Bucharest Metropolitan Area
• Led the Software development for tado’s Thread Border Routers • Implemented Thread & Matter for tadoX • Led Device Platform & CI/CD development • Presented tadoX Thread solution as a Guest Speaker at Thread Members Meeting Autumn 2024
Founder
Growthread DevelopmentFreelance
Mar 2022 - Present
4 years 8 months
Bucharest, Romania
Skills: SaMD · Medical Device R&D · IEC 62304 · IEC 60601 · Risk Management
Operational and Technical Manager
Evolution MedTec (Cicor Group)
Nov 2018 - May 2022
3 years 7 months
Bucharest, Romania
• Transitioned the company into a self-sustaining business model, successfully acquiring the first clients. • Updated SOPs and increased automation, significantly reducing project delivery times. • Expanded the team by 25% to meet evolving project demands, enhancing overall productivity. • Led the development of multiple Class II and Class III Active Medical Devices, ensuring compliance and quality.
Exceet Medtec Romania
Mar 2014 - Dec 2018
4 years 10 months
Bucharest, Romania
Head Of Software Development
May 2016 - Dec 2018
2 years 8 months
Bucharest, Romania
• Developed, implemented and documented software requirements, risk analysis, and testing protocols • Planed, organized and controlled medical projects (with a focus on the software/firmware aspects) • Performed and coordinated software risk analyses and documentation according to ISO 14971 • Developed new SOPs for the software department to serve as guidelines for future projects (Development Plan, Architecture design document, Internal working procedure, Coding Guideline, etc)
Embedded Software Engineer
Mar 2014 - May 2016
2 years 3 months
Bucharest, Romania
• Developed high integrity firmware for medical class devices (IEC 62304 class B & C) using different microcontrollers (ARM-Cortex M0/3/4, MSP430) • Tested and debugged the developed firmware using software and hardware tools (oscilloscope, logic analyzer) in a multi-functional team • Developed unit and integration testing protocols. Performed the tests.
Embedded Software Engineer
Valtronic
Aug 2011 - Mar 2014
2 years 8 months
Bucharest, Romania
• Developed firmware for medical class devices using different low power microcontrollers (ARM-Cortex M) • Tested and debugged firmware using software and hardware tools (oscilloscope, logic analyzer)
Hardware Design Engineer
Elinktron Technology
Jun 2007 - Aug 2011
4 years 3 months
Bucharest, Romania
Design, Layout and FPGA design for complex high speed boards
Education
University POLITEHNICA of Bucharest
MSc
2010 - 2012
2 years 1 month
University POLITEHNICA of Bucharest
BSc
2004 - 2009
5 years 1 month
Liceul Teoretic Petrosani
2000 - 2004
4 years 1 month