Kai Medical is seeking an expert to manage the Company’s quality and regulatory activities related to Class II medical device product development and manufacturing. Responsibilities include development and execution of regulatory strategies, obtaining regulatory approval for Kai’s medical device products, enhancing and maintaining the Quality Management System, creating and implementing a CAPA system and a complaint management system, managing the document control and change control processes, overseeing design control for products in development, performing audits, ensuring compliance of clinical trials with relevant regulations, and maintaining training records.
Applicants should have direct quality and/or regulatory experience supporting product design control and/or regulatory submissions of class II or class III medical device products, working knowledge of FDA QSRs, ISO 13485, ISO 14971, and IEC 60601. Experience managing quality and regulatory activities at a startup company, experience formulating and implementing quality and regulatory strategies, experience preparing complex 510(k) submissions or PMA submissions, and experience writing clear and effective SOPs that are readily adopted by the employees is highly desirable. ASQ/AQE/CQA certification is desired.
Kai Medical is seeking an experienced engineer to help develop and improve physiological signal processing, radar signal processing, and other algorithms and software for the Company’s medical device products. Job responsibilities will include the development of signal processing algorithms for Doppler radar-based vital signs measurement and patient monitoring devices, and development, documentation, and testing of software for these devices.
Applicants should have a Ph.D. in Electrical Engineering, Computer Science, Biomedical Engineering, or similar, or a M.S. degree with several years of experience.
Applicants must have developed successful algorithms to enhance and extract information from physiological signals. Expertise programming in both MatLab and C, experience working in a fast-paced environment, experience developing, documenting, and testing software for Class II or Class III medical devices, experience in developing patient monitoring devices, and experience in signal processing for ultrasound or Doppler radar is highly desirable.
