Senior Specialist, DTx Quality Engineer

Click Therapeutics is at the forefront of digital therapeutics innovation, developing FDA-regulated prescription treatments delivered through smartphones. As a Senior Specialist, DTx Quality Engineer, you'll play a crucial role in developing Software as Medical Device (SaMD) products.

The position involves working closely with Product Management, Software Engineering, and Testing teams to drive product quality activities and implement Quality Management System procedures in alignment with FDA and international medical device regulations. You'll report to the Senior Manager of DTx Quality Engineering and directly impact bringing medical device software to market.

This contract position offers the opportunity to work with cutting-edge digital therapeutics addressing various medical needs across psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. You'll be responsible for implementing software development lifecycle processes, cybersecurity measures, and risk management for multiple ex-US SaMD products.

The role requires expertise in international medical device regulations and standards, including UK Medical Device Regulation, EU MDR, and ISO 13485. You'll prepare design control deliverables, coordinate with ex-US quality and regulatory roles, and manage regulatory submissions.

Click Therapeutics offers a collaborative environment consistently rated as a best place to work, bringing together innovators, clinicians, scientists, researchers, and engineers. The position provides competitive hourly compensation and flexible equipment choice.

Join a company committed to making a difference in healthcare through digital therapeutics, working alongside diverse professionals united in the mission to provide accessible, effective prescription digital treatments to patients worldwide.