SaMD Quality Intern

Who We Are:

Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click’s treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click’s platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit www.clicktherapeutics.com and connect with us on LinkedIn. 

About the Role:

We are looking for an ambitious and detail-oriented intern to work with the Click Quality Team and Quality Management Systems (QMS) to support development of software as a medical device (SaMD) products. During your time at Click, you will be introduced to a burgeoning sector of the health tech industry and have the opportunity to learn medical device quality system principles, how they apply to Agile software development, and work within cross-functional teams to implement and facilitate quality system processes. This is a tremendous learning opportunity to gain an understanding of medical device development processes and the software development life cycle in a regulated environment.

This position is based out of Click’s headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. This is a hybrid internship in which you will come to the office Wednesdays and Fridays.

Responsibilities:

• Participate in the implementation and oversight of Click’s Quality Management System (QMS) processes throughout the organization.
• Support product development processes, such as risk management and design review, to ensure product development compliance with regulatory and quality standards throughout the Software Development Lifecycle.
• Work within Click’s electronic QMS document management system with CAPA records, complaints, training records, etc.
• Review design documentation including product requirements, design specifications, verification/validation test plans and reports. Maintain records as part of the products’Design History File (DHF).
• Enhance quality system procedures to enable on-going process improvements and the expansion of Click’s quality system to support product commercialization in world-wide markets.
• Research and monitor SaMD and DTx industry trends and publications, FDA news and announcements, and international standards. Apply learnings to the Quality Management System.

Qualifications:

• Rising Sophomore or Junior currently pursuing an undergraduate degree. 
• Excellent verbal and written communication skills.
• Detail oriented, with consistent organizational skills.
• Enthusiastic about digital health and healthcare innovation.

Preferred Qualifications:

• Pursuing a degree in Biomedical Engineering, Biological Engineering, or similar.
• Experience writing SOPs or other technical writing (in a science or engineering field). 
• Familiarity /  working knowledge of software programming language(s). 
• Working knowledge of medical device standards and regulations such as FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.

Compensation: $22/hr

Hours and Duration: 

This is a part-time, 30 hours/week position. The internship will have a duration of 10 weeks, from May 20th - August 1st, 2025.

Benefits:

Mac Laptop | Sponsored Company Even