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 Tuesday and Thursday.

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 Junior or Senior Undergrad.
• Current student of a 4-year program with a strong academic record.
• 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 11 weeks, from May 15th - July 26th 2024.

Benefits:

Mac Laptop | Grubhub | Sponsored Company Events | Unlimited Office Snacks and Beverages | Much More…

Equal Employment Opportunity:

Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics.

Recruitment Phishing Scams: 

As recruitment phishing scams are growing, we urge you to be vigilant during the job search process. Please be mindful of the following:

• Click Therapeutics will only reach out to you through an “@clicktherapeutics.com” email address.
• Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver’s License Number) via email or a messaging application (like that used on the LinkedIn platform).
• Click Therapeutics will conduct interviews face-to-face over Zoom.
• All job postings will be listed on the Click Therapeutics official career page. If someone contacts you about a job or position that is not listed on the official career page, please contact the Click Therapeutics recruitment team at the contact information below.
• If you have any questions regarding the validity of a recruitment inquiry or an interview, please contact the Click’s recruitment team at recruitment@clicktherapeutics.com to confirm before proceeding.

If you encounter a scam, report it to the Federal Trade Commission at https://reportfraud.ftc.gov/#/

Salary : $22