Purpose of the Job:
The Director, Smart Device Engineering manages the US Smart Device group at the San Ramon Facility to develop and execute strategies and plans consistent with Company Goals in an ever-changing regulatory climate. The Director, Smart Device Engineering ensures that U.S. Corporate Smart Device initiatives are planned, developed and delivered in a compliant and timely manner and that strategies, SOP’s and development processes are executed. This position ensures design and development compliance in a fast evolving developmental, medical device, clinical laboratory and commercial environment. The Director, Smart Device Engineering will prepare, test, evaluate and oversee compliant Smart Device strategies.
Reporting to the Global Head of Smart Devices, this role will manage design engineering professional staff and/or consultants and direct and implement advancement of the U.S. Smart Device functions at iCarbonX. They will also be responsible for identifying and helping prioritize critical partnerships in this area.
Major Duties and Responsibilities
- Design next generation systems of wearable and other smart sensors
- Work closely with the iCarbonX Smart Devices China team to rapidly develop concept to prototype, including both hardware and software components
- Keep up to date on the most current technologies in the area of smart devices
- Build a small U.S. focused engineering team
- Ph.D. or Masters degree in Electrical, Mechanical or Biomedical Engineering
- 10+ years of system level design of hardware products
- Proficient in PCB schematic & layout
- Experience with digital signal processing (FFT, filters), data analysis in MATLAB/Python
- Experience with sensor algorithm development
- 10+ years of industry experience leading teams in wearable devices or consumer electronics
- Experience with wearable devices and smart sensors or miniaturization
- Experience with analyzing a large amount of data using statistical tools
- Experience with R&D environment and independent explorations
- Working knowledge of FDA Quality System Regulations (21 CFR Part 820 and Part 11), ISO 13485 (Quality Management for Medical Devices, and IEC62304. IEC 60602, IEC 60601 IEC 62366 IEC 62604
Special Skills, Abilities, and Requirements:
- Exceptional written, oral, and interpersonal communication skills.
- Experience in research and consumer products which are then further developed into diagnostic and medical devices preferred.
- Strong management and cross-group skills, including the ability to get what you need from others while working around their own legitimate priorities.
- Ability to work in a complex, rapidly changing environment
- Excellent project management skills
- Strong leadership and mentoring skills
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive
- Demonstrated strong problem solving and risk management skills.
- Mandarin language skills strongly desired.
In April 2018, we formed the iCarbonX group with the merger of 3 companies - iCarbonX, PatientsLikeMe, and HealthTell. Our vision is to fundamentally transform the healthcare & wellness of individuals & communities by unlocking the power of deep & dynamic digitization of biological information. By combining multi-omics biological data, smart device biophysical data and patient’s phenotypic data with artificial intelligence, iCarbonX will enable a real-time, deep assessment on one’s health and wellness, and deliver a personalized guide and range of products to help people live a healthy, longer life. To achieve our vision, we are developing state of the art multi-omics technology platforms to digitalize biological data and apply insights gained from the process into development of medical and wellness products.
iCarbonX is an equal opportunity employer.