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 Specialist, DTx (Digital Therapeutics) Quality Engineer is a contract position that 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 Specialist, DTx Quality Engineer reports to the Senior Manager of DTx Quality Engineering and has a direct role in bringing Click medical device software to the market.
Responsibilities:
- Work cross-functionally throughout the organization to implement and champion software development lifecycle (SDLC), cybersecurity, and risk management processes for multiple ex-US SaMD products in various stages of development.
- Establish Quality System processes and procedures that comply with applicable regulations, standards and guidance for the design, development, and manufacture of SaMD in ex-US jurisdictions (e.g., United Kingdom, European Union member states, Japan).
- Develop product-specific expertise to prepare high-quality design control deliverables and records for ex-US SaMD products (e.g., SaMD product requirements and specifications, infrastructure qualification, software architecture, data flows, traceability tables, anomaly logs, risk management files).
- Coordinate and collaborate with the designated ex-US quality and regulatory roles (e.g., Person Responsible for Regulatory Compliance (PRRC), EU Authorized Representative, Importer) to ensure submissions, product registration, labeling, and post-market surveillance activities are conducted in accordance with relevant regulations.
- Oversee and manage the submission of required documentation and information to regulatory agencies, notified bodies, and applicable registrar databases (e.g., the European Union Database on Medical Devices (EUDAMED)).
- Identify and coach team members on industry best-practices and key-learnings between ex-US SaMD products for the consistent and optimal implementation of the quality system across the organization.
- Lead Quality System efforts with Click’s collaborative partners to effectively execute design and development activities between multiple manufactures according to relevant Quality Agreements.
- Promote a culture of quality and advocate for the importance of product quality throughout the organization.
Qualifications:
- Bachelor’s Degree in engineering or other STEM related field, advanced degree preferred.
- 5+ years of experience working in a medical device quality system.
- Advanced knowledge of medical device international regulation and standards including UK Medical Device Regulation, EU Medical Device Regulation (EU MDR), Pharmaceutical and Medical Device Act (PMDA), and ISO 13485, additional understanding of international regulations preferred such as ISO 27001, IEC 81001-5-1, MDSAP, EU Artificial Intelligence Act, and DiGAV.
- Prior experience working with software products through the full product lifecycle with knowledge of SDLC, including familiarity with relevant SaMD standards and methodologies such as IEC 62304, AAMI TIR 45.
- Experience supervising quality engineering / design control activities across multiple simultaneous projects.
- Strong verbal and written communication skills to translate procedures into practice and effectively work with interdisciplinary teams and stakeholders.
Compensation:
$130 - $140 per hour.
Hours:
20 hours per week through 2025.
Benefits:
Choice between a Mac or Linux equipment.
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 [email protected] to confirm before proceeding.
If you encounter a scam, report it to the Federal Trade Commission at https://reportfraud.ftc.gov/#/
