DTx Quality Engineer (Medtech)

TL;DR

DTx Quality Engineer (Medtech): Managing complaint records and ensuring regulatory compliance for prescription software as medical treatments with an accent on SaMD standards and risk management. Focus on maintaining audit readiness, performing trend analysis on complaints, and coordinating software verification for formal releases.

Location: New York, NY

Salary: $100–$120 per hour (20 hours/week)

Company

Leading innovator of Digital Therapeutics™ developing FDA-regulated prescription software treatments for unmet medical needs.

What you will do

• Manage complaint records for investigational and commercial SaMD applications from receipt to closure in a compliant manner.
• Ensure all records maintain audit readiness and comply with internal procedures and regulatory requirements.
• Coordinate with cross-functional teams to determine root causes of issues and perform trend analysis on complaints.
• Support release management by coordinating software verification and creating testing plans, reports, and traceability documentation.
• Maintain logs of software anomalies and ensure Design & Development Files are updated according to regulations.
• Lead interdisciplinary design reviews and establish product risk assessments and controls.

Requirements

• Bachelor’s Degree in engineering or equivalent experience.
• 1-5 years of experience in a medical device, software, or technology field.
• Experience working with medical device quality management systems (Required).
• Familiarity with SaMD standards and regulations such as FDA 21 CFR 820, ISO 13485, and IEC 62304 (Required).
• Must have authorization to work in the U.S.
• Proven ability to integrate AI technologies to drive innovation.

Nice to have

• Experience working with software products through the full lifecycle with knowledge of iterative agile planning.
• Experience working with eQMS systems such as Enzyme or Ketryx.

Culture & Benefits

• Inclusive and diverse workforce of innovators, clinicians, and scientists.
• Consistently named a best place to work.
• Mission-driven environment focused on providing safe and effective prescription digital therapeutics.