Senior DTx Quality Engineer
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.