Description
Summary
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?
Description
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.
Key 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
Apple