Who We Are:
Click Therapeutics, Inc. develops and commercializes software as prescription medical treatments for patients with unmet medical needs. Through cognitive and neurobehavioral mechanisms, Click’s Digital Therapeutics™ enable change within individuals and are designed to be used independently or in conjunction with biomedical treatments.
The Clickometrics® adaptive data science platform continuously personalizes user experience to optimize engagement and outcomes. Click is progressing a broad pipeline of Digital Therapeutics™ across a variety of high-burden therapeutic areas, including Major Depressive Disorder, Schizophrenia, Migraine, Multiple Sclerosis, Chronic Pain, Atopic Dermatitis, Acute Coronary Syndrome, Obesity, Oncology, and more. For more information on Click, visit ClickTherapeutics.com.
About the Role:
The DTx (Digital Therapeutic) Quality Engineer has a key role in the development of Click’s Software as a Medical Device (SaMD) product. This position works alongside the Product Management, 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 DTx Quality Engineer reports to the Manager of DTx 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.
- Drive product development processes, from a quality perspective, to ensure product development compliance with regulatory and quality standards throughout the Software Development Lifecycle.
- Identify and innovate in areas where manual work can be automated and drive ongoing process improvements and collaborate with the quality management team to enhance procedures.
- 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.
- Lead interdisciplinary design reviews at major product development milestones.
- Coordinate quality aspects of release management including the scheduling and execution of software verification, clinical validation, and formal release.
- Work closely with Click’s collaborative partners to effectively execute design and development activities.
- Enable clear communication, prioritization, and decision-making across teams to efficiently document and help manage the handling of product changes and incidents per Click’s quality management procedures.
- Maintain the products’ Design History File (DHF) for anticipated 510(k) submissions when applicable.
- Bachelor’s Degree, preferably in engineering.
- 1- 5 years of experience in a medical device, software, or another technical 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).
- Preferred: Experience working with software products through a full lifecycle with knowledge of iterative agile planning, development, and delivery.
- Preferred: Experience working with quality management systems.
- Preferred: Familiarity with relevant SaMD standards and regulations such as FDA 21 CFR 820 and ISO 13485.
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.
Stock options | Competitive Salary with Annual Review | 5% 401(k) matching | Annual Performance-Based Cash Bonus | Comprehensive Medical Benefits | Dental | Vision | Voluntary Benefits | Unlimited Vacation Time | Uber One | Nectar Rewards | One Medical | Fertility Support | Gym Pass | Citi Bike | Professional Development Stipend | Industrious Workspaces | Generous Paid Parental Leave | Commuter Subsidies | Weekly Catered Lunches | Choice of Mac or Windows | Sponsored Company Events | Free, 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 the 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 the availability of qualified U.S. workers and the colleague’s long-term prospects for securing a lawful permanent residence, among other reasons.
Employment applicants requiring immigration sponsorship must disclose when an 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 the 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 Click’s recruitment team at firstname.lastname@example.org to confirm before proceeding.
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