Senior DTx Quality Engineer

The role

The Senior DTx Quality Engineer drives product development compliance and quality activities for Software as a Medical Device products. This role works with Product Management, Software Engineering, and Testing teams to implement Quality Management System procedures.

What you will do

• Drive product development processes to ensure compliance with regulatory and quality standards.
• Drive ongoing process improvements and collaborate with technical teams in an Agile framework.
• Lead product risk management activities and establish risk assessments.
• Monitor, manage, mitigate, and communicate product risks.
• Develop and review design documentation including requirements, specifications, and test plans.
• Maintain records as part of the products Design and Development File.
• Manage post-production activities including complaint handling, data analysis, and defect tracking.
• Enable communication and decision making across teams using post-production data.
• Implement change control.

Required qualifications

• Bachelor’s Degree
• 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
• Seamlessly integrated AI into professional workflow and personal productivity

Nice to have

• 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
• Engineering degree

Benefits

• Competitive Salary with Annual Review
• Cash Bonus
• Stock Options
• 401(k) matching
• Medical
• Dental
• Vision
• Life Insurance
• Voluntary Benefits
• Unlimited PTO
• Uber One
• Nectar Rewards

Before you apply

• Must have authorization to work for Click Therapeutics in the U.S.
• Applicants requiring immigration sponsorship must disclose legal authorization to work in the U.S.

About the company

Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. The company delivers FDA-regulated prescription treatments via smartphone using technical and scientific rigor.