Chrouk Kasem Email & Phone Number

Boston, Ma, Us

In my role as Senior Manager of Software Development at MY01, I led the software department by managing the total product lifecycle for various medical device and companion products. This included overseeing software design and development activities, V&V, cybersecurity, and compliance testing for FDA submissions, as well as managing the development and release of key IoT solutions to enhance product connectivity and drive sales growth. I also worked on privacy and security considerations including corporate governance such as SOC 2, IT assessments, HIPAA assessments.I also spearhead engineering field support activities which include support for the sales team on education of the engineering of the medical device product.

As a Software Developer Lead at MY01, I spearheaded the implementation of software team development and maintenance processes, including security procedures. My team and I successfully maintained medical device embedded software in C, while also developing various software applications in C# and Python for internal manufacturing processes. Adhering to guidelines on GMP and software validation, we ensured the support software met industry standards.

Montreal, Quebec, Canada

Montreal, Quebec, Canada

As a Medical Device Engineering Consultant at PTL Solutions Inc., I lead software development for medical devices, including guidance on design control, risk assessments, FDA cybersecurity requirements and software lifecycle processes per IEC 62304.• Developed and reviewed software for Class I to Class III medical devices per FDA requirements.• Conducted FMEA reviews for medical devices with software to evaluate risks in normal and fault conditions.• Reviewed documentation per latest FDA cybersecurity requirements.• Provided guidance on IEC 62304: Software Development Lifecycle.

Master Of Engineering - Meng, Telecommunications And Signal Processing

Bachelor’S Degree, Electrical Engineering