Systems Engineer - Health Software
Core
Develop, manage, and maintain design history files and regulatory deliverables for Apple's regulated health software features.
Role type
Senior Systems Engineer (Regulatory & Design Controls)
Builds
Regulated health software features (Software as a Medical Device)
Domain
Health technology / Medical device regulation
Required skills
Software architecture, regulatory compliance (SaMD), stakeholder alignment, impact analysis, process improvement, technical writing
Preferred skills
Quality management systems (21CFR820, ISO 13485, IEC 62304, ISO 14971), China medical device regulations, Python/shell scripting, AI tools for prototyping
Technologies
Python, shell scripting, AI tools
Responsibilities
Develop and maintain design history files and regulatory deliverables; Translate complex technical and regulatory concepts for diverse audiences; Conduct impact analysis on design changes; Partner with cross-functional stakeholders to translate product vision into traceable engineering requirements; Identify and implement process improvements including building software tools and prototypes; Travel internationally to China to assist in local engineering activities and software testing
Seniority
Senior, hands-on IC
