DTx Quality Engineer, Click Therapeutics

• Bachelor’s Degree, preferably in engineering
• 0-2 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)

Desirable

• 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 DTx Quality Engineer reports to the Manager of DTx Quality and has a direct role in bringing Click medical device software to the market
• 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. Maintain records as part of the products’ Design History File (DHF)
• 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
• Work closely with Click’s collaborative partners to effectively execute design and development activities