Apple
Systems Engineer - Health Software
$142K–$278K
San Diego, California +1 · Full-time · Posted Sep 22, 2026
- Location
- San Diego, California
Sunnyvale, California - Experience
- 7+ years of relevant industry experience, or equivalent combination of education and professional experience.
- Education
- Bachelor’s degree in a technical field, or equivalent combination of education and professional experience.
About the job
Supports regulated health software development by managing regulatory documentation, translating requirements, assessing design changes, and coordinating engineering work across teams.
What you'll do
- Develop, manage, and maintain design history files and regulatory deliverables.
- Translate product vision into traceable engineering requirements and safe, scalable designs; assess design changes and facilitate stakeholder trade-offs.
- Travel to China for local engineering activities, including software testing, and implement process improvements such as tools or prototypes.
What they ask for
- Bachelor’s degree in a technical field with 7+ years of relevant industry experience, or equivalent combination of education and professional experience.
- Medical device development experience, particularly Software as a Medical Device (SaMD) or other regulated software products.
- Strong technical fluency in software architecture and development processes.
- Willingness to travel internationally (~10%); strong communication and stakeholder-alignment skills.
Nice to have
- Quality management systems/design controls knowledge, such as 21CFR820, ISO 13485, IEC 62304, or ISO 14971; China medical device regulations and GMP; Mandarin.
- Regulatory submission writing, project/program management, Python and/or shell scripting, or AI tools for software development or prototyping.
Pay
$142,300 and $263,300 (base salary); $150,400 and $277,600 (base salary)
Tools
Python, shell scripting, 21CFR820, ISO 13485, IEC 62304, ISO 14971
AI focus
Preferred experience using AI tools for software development or prototyping.
Model-written summary · the original posting is authoritative