Apple is looking to develop health features for its users, which are safety-critical consumer software requiring regulatory approval and adherence to rigorous ISO standards. The company needs a Systems Engineer to bridge innovation and regulation, ensuring the successful development and launch of these health features.
Requirements
- Experience with Software as a Medical Device (SaMD) development
- Exposure to regulatory and quality systems including design controls, risk management, and verification/validation activities
Responsibilities
- Support design and architecture of health regulatory and sensor software applications
- Collaborate with cross-functional partners to translate bold product visions into actionable user requirements and engineering designs
- Translate complex technical and regulatory concepts for diverse audiences, from engineers to executives
- Lead strategic initiatives that increase product development efficiency and scalability, and process optimization
- Develop, manage, and maintain design history files and regulatory deliverables
- Conduct impact analysis on design changes and facilitate trade-off discussions across stakeholder groups
Other
- Proven technical leadership with experience bridging cross-functional teams, the ability to influence without authority
- Bachelor's degree with 5+ years of relevant industry experience OR equivalent combination of education and professional experience
- Exceptional written communication, negotiation, and presentation skills
- Ability to balance the big picture with a keen eye for detail
- Excellent interpersonal skills and ability to work well with all levels of engineers and other teams
