Develop and document software and firmware in compliance with Quality System, regulatory requirements and applicable standards that address Marketing requirements and project needs.
Design and develop embedded systems including firmware, software, user interface and algorithm development.
Develop and document designs in compliance with Quality System, regulatory requirements and applicable standards that address Marketing requirements and project needs ie 21 CFR820 and ISO 1348:2016.
Provide guidance and understanding to navigate complex product certifications and industry regulations to include CE, UL, IEC,ISO 13485, 21 CFR 820 and ISO-14971:2019.