12 hours ago
Responsibilities
- Connect teams and disciplines across regulated Health Software projects.
- Drive alignment and decisions across diverse stakeholder groups.
- Engage engineering teams in substantive discussions about software architecture and development processes.
- Reason across multiple levels of abstraction, treating systems as black boxes when appropriate and investigating relevant internal details.
- Contribute to the development of regulated software as a medical device.
- Support technical writing, documentation, and potentially regulatory submissions.
- Travel internationally approximately 10% of the time.
Requirements
- Bachelor’s degree in a technical field and 7+ years of relevant industry experience, or an equivalent combination of education and professional experience.
- Experience developing medical devices, particularly Software as a Medical Device or other regulated software products.
- Strong technical fluency in software architecture and development processes.
- A track record of driving alignment and decisions across diverse stakeholder groups.
- Excellent written and verbal communication skills.
- Preferred knowledge of quality management systems and design controls, including 21 CFR 820, ISO 13485, IEC 62304, or ISO 14971.
- Preferred experience with regulatory submissions, project or program management, China medical-device regulations, and GMP.
- Preferred proficiency in Mandarin.
- Preferred experience with Python and/or shell scripting.
- Preferred experience with AI tools for software development or prototyping.
Tech Stack
About Apple
Apple designs and sells consumer electronics, software, and services for consumers and professionals worldwide, including iPhone, Mac, iPad, Apple Watch, and AirPods, plus platforms like iOS/macOS and services such as the App Store, iCloud, Music, and TV+. Its business combines device sales with services and subscriptions and in-house silicon design. Founded in 1976, Apple is headquartered in Cupertino, California, and trades on NASDAQ as AAPL.