Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.

To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.

Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.

Our Quality Manager will leverage operational experience to meet quality and regulatory goals, define processes within a medical device product area. Establish processes and deliverables for medical device product development programs per the FDA and ISO requirements for Cardiosense Hardware and SaMD products. You will be pioneering this critical role for an exciting start-up in the medical device space.

Specific responsibilities:

• Collaborate with hardware, systems and software engineering and other product development teams in establishing standard operating procedures for the definition of design history file (DHF) and device master record (DMR) deliverables.
• Guide medical device development teams in their execution strategy for Design and Risk SOPs, review, approve, and audit DHF elements (e.g., plans, requirements, specifications, test protocols, test results, design traceability, risk management documents, design reviews, reports).
• Train and coach cross-functional peers on maintaining compliance to internal and external medical device quality system requirements and regulations.
• Perform internal audits and possible contract manufacturer audits to verify compliance with QMS requirements for design, development, and manufacturing of medical devices.
• Establish growth plans and hire excellent talent to the organization that intelligently scales with the business needs.

• Experience with establishing Hardware quality management for medical devices is a must.
• Bachelor’s Degree in Biomedical, Mechanical or Electrical Engineering or other Technical Science.
• 10 years of work experience in a highly regulated industry (e.g., Medical Devices, Bioengineering, LifeSciences, Quality and/or Development).
• Experience in the application of ISO 13485, ISO 14971, 21 CFR 820 and other US regulations, IEC 62304, IEC 60601-1, MDD & EU MDR.
• Experience authoring technical reports, business correspondence and standard operating procedures.
• Proven communication skills. Experience presenting clearly and persuasively to technical and non-technical audience.
• Proven leadership qualities in hiring and retaining top talent, championing new initiatives in a large organization, and representing the organization to outside regulatory agencies.
• Experience electronic Quality Management System tools for best in class documentation and record keeping practices.
• Prior experience establishing a new QMS.
• Experience with Hardware devices as well as Software as a Medical Device product development.

Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.