Summary

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

Job description

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. 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

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)

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

Requirements

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
Attention to detail and ability to generate clear technical documentation/records
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

Benefits

401(k) Matching
Medical, Dental & Vision
Life Insurance
Unlimited PTO
Stock Options
Annual Cash Bonus
Fitness Reimbursement
Bike Reimbursement
Professional Development Reimbursement
Commuter Subsidies
Parental Benefits
Flexible Work Arrangement

Company overview

Click Therapeutics is a pioneering digital therapeutics company that develops, validates, and commercializes software as prescription medical treatments for patients with unmet medical needs. Founded in 2012 and headquartered in New York City, the company has established itself as a leading innovator in the Digital Therapeutics™ space, delivering FDA-regulated prescription treatments directly to patients' smartphones. Click Therapeutics employs a rigorous scientific approach combined with patient-centric design to create engaging digital experiences that achieve compelling clinical outcomes. The company's platform incorporates advanced technologies including artificial intelligence, machine learning, and novel cognitive, behavioral, and neuromodulatory mechanisms of action. Their digital therapeutics pipeline addresses diverse therapeutic areas including psychiatry, neurology, oncology, cardiology, and immunology. With a workforce of 130-200 employees comprising clinicians, scientists, researchers, designers, and engineers, Click Therapeutics has secured significant funding including a recent $48.6M Series C round and maintains strategic partnerships with major pharmaceutical companies like Boehringer Ingelheim.