Senior DTx Quality Engineer

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:

The Senior DTx (Digital Therapeutic) Quality Engineer has a key role in the development of Click’s Software as a Medical Device (SaMD) products. This position works alongside the Product Management, Software Engineering, and Testing teams and drives the day-to-day product quality activities while implementing Quality Management System (QMS) procedures in alignment with evolving FDA and international medical device regulations. The Senior DTx Quality Engineer reports to the Associate Director, Regulatory & Quality and has a direct role in bringing Click medical device software to the market.

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. We have a hybrid working model that consists of at least 4 days in office each week.

Responsibilities:

Drive product development processes, from a quality perspective, to ensure product development compliance with regulatory and quality standards throughout the Software Development Lifecycle.

Drive on-going process improvements and collaborate with the technical teams to enhance implementation of procedures in an Agile framework.

Lead product risk management activities to establish product risk assessments and trace the implementation of risk controls. Actively monitor for product risks, manage/mitigate where possible and communicate/escalate as needed.

In coordination with the technical teams, develop and review design documentation including product requirements, design specifications, verification/validation test plans and reports, and traceability tables. Maintain records as part of the products’ Design and Development File.

Manage post-production activities including complaint handling, data analysis, and defect tracking.

Enable clear communication, prioritization, and decision making across multiple teams using post-production data to inform product updates and enhancements while implementing change control.

Qualifications:

At Click, we aren't just looking for talent; we are looking for the next evolution of the modern professional. To us, AI is not a future possibility, it is a present-day prerequisite. We expect every Click colleague to have seamlessly integrated AI into their professional workflow and personal productivity, using it as a force multiplier to move faster, think deeper, and deliver superlative results that were previously out of reach. If you do not yet view AI as an essential partner in your daily pursuit of excellence, you will find it impossible to keep pace with our mission. High performers who harness AI technology to transcend traditional boundaries and set new benchmarks for professional excellence will thrive at Click.

Bachelor’s Degree, preferably in engineering 1-5 years of experience working in a medical device, software, or other technology field

Ability to oversee quality management activities within multiple simultaneous projects

Strong verbal and written communication skills to translate procedures into practice and effectively work with interdisciplinary teams and stakeholders

Attention to detail and ability to generate clear technical documentation/records (i.e., protocols, reports, test methods, justifications)

Click Preferred Qualifications:

Experience working with software products through full lifecycle with knowledge of iterative agile planning, development and delivery

Proficiency in medical device quality system regulation and standards including ISO 13485.

Familiarity with relevant SaMD standards and methodologies such as IEC 62304, IEC 14971, AAMI TIR 45

Compensation:

The base salary range for this position is between $120,000 - $142,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package.

Benefits:

The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space.

Competitive Salary with Annual Review | Cash Bonus | Stock Options | 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fitness Reimbursement | Bike Reimbursement | Professional Development Reimbursement | DoorDash Lunches | Parental Benefits | Gemini Enterprise Stack | Claude | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Sponsored Company Events | 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 app