Senior Software Quality Engineer | Digital Health AI | REMOTE

Join a fast growth digital health – Software Medical Device (SaMD) company that is leveraging AI and Machine Learning to dramatically improve the way disease is diagnosed.

This is a 100% REMOTE based role with minimal travel (5% at the most).

As this team grows, we are looking for a software quality engineering professionals with 4-20 years of experience applying and guiding development in accordance with IEC 62304, 14971, and 13485. Qualified applicants will have an expert or near expert understanding of IEC 62304.

Key Responsibilities:

• Support the QMS for a fast growth digital health company contributing to the cure of major diseases

• Directly support product development teams in the design of Software as a Medical Device

• Conduct software validations, to include plans, protocols and reports; serving as a liaison-consultant to engineering and manufacturing teams throughout the design control process

• Support compliance in all phases of design and development, manufacture, and product release

Requirements

Minimum of a bachelor’s degree in an appropriate scientific or other related field

• 4-20 years of experience in a software quality role within the medical device, emerging medtech or digital health space. Other life sciences experience may be considered.

• Hands-on ability to work autonomously to problem-solve, demonstrating excellent analytical skills

• Expert level understanding of IEC 62304 and experience with its implementation in design and development

• Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971

• Superior verbal and oral communication skills and intellectual curiousity