As a Systems Engineer in Health Software at Apple, you will play a crucial role in developing regulated health features that enhance the lives of users worldwide. This position requires collaboration across various teams and disciplines, focusing on innovation within the regulatory landscape. You will be part of a small, dedicated team that values quality and purposeful work. If you are passionate about making a positive impact through software as a medical device, this role is for you.

• 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.
• 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.
• Knowledge of quality management systems and design controls 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.

• Connect teams and disciplines to ensure alignment on regulated projects.
• Engage in substantive discussions with engineering teams regarding software architecture.
• Drive decisions across diverse stakeholder groups to facilitate project progress.
• Contribute to the development of software as a medical device.
• Ensure compliance with relevant medical device regulations and quality management standards.
• Prepare and maintain technical documentation for regulatory submissions.
• Manage projects in complex, multi-disciplinary technical environments.

• Employees at Apple are often offered comprehensive benefits that support physical and mental well-being—flexible medical plans, confidential counseling, onsite wellness centers at major campuses, and resources for fitness and daily life. Families typically receive fertility support, paid parental leave with gradual return, caregiving leave, and dependent-care guidance, while financial perks commonly include stock grants (with purchase discounts), 401(k) matching, and income-protection coverage. Employees also see robust time off, Apple University learning and tuition reimbursement, donation matching and paid volunteer hours, and deep product and partner discounts.