Systems Engineer - Health Software

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., * 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

• 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, * 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

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $142,300 and $263,300, and your base pay will depend on your skills, qualifications, experience, and location. Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan. You’ll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this

Make a Life-Changing ImpactReady to improve the lives of millions of people around the world by helping Apple ship regulated health features that users rely on every day?