Systems Engineer - Health Software

Make a Life-Changing Impact

Ready to improve the lives of millions of people around the world by helping Apple ship regulated health features that users rely on every day?

As a Systems Engineer in Health Software, you'll be at the intersection of innovation and regulation — seeing the big picture across regulated projects, connecting teams and disciplines, and doing work that genuinely matters. We're a small team that values collaboration, each other, and quality, and we're looking for someone energized by purposeful work in a complex space. If you're inspired to make the world a better place through software as a medical device, we'd love to hear from you.

Responsibilities

• Develop, manage, and maintain design history files and regulatory deliverables
• Translate complex technical and regulatory concepts for diverse audiences across Apple
• Travel internationally to China to assist in local engineering activities, including software testing
• Conduct impact analysis on design changes and facilitate trade-off discussions across stakeholders
• Partner with cross-functional stakeholders to translate product vision into traceable engineering requirements and safe, scalable designs
• Identify and implement process improvements, including building software tools and prototypes where applicable

Minimum Qualifications

• Bachelor’s degree in a technical field with 7+ years of relevant industry experience OR equivalent combination of education and professional experience
• Willingness to travel internationally (~10%)
• 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, including the ability to hold substantive discussions with engineering teams
• Track record of driving alignment and decisions across diverse stakeholder groups
• Excellent written and verbal communication skills
• Ability to reason at multiple levels of abstraction — knowing when to treat something as a black box and when to dig into details that matter inside of it

Preferred Qualifications

• Quality management systems and design controls knowledge such as 21CFR820, ISO 13485, IEC 62304, or ISO 14971.
• Strong technical writing and documentation skills, preferably including experience with regulatory submissions
• Project/program management experience in complex, multi-disciplinary technical environments
• Knowledge of China medical device regulations and GMP
• Proficiency in Mandarin
• Experience with Python and/or shell scripting
• Experience with AI tools for software development or prototyping