Apple is looking to develop health features for their devices that require regulatory approval and meet rigorous ISO standards. The company needs a Systems Engineer to work on safety-critical consumer software, bridging innovation and regulation.
Requirements
- Proven technical leadership with experience bridging cross-functional teams, the ability to influence without authority
- 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
- Ability to influence without authority
- Cut through ambiguity, communicate with clarity, and learn new domains quickly
- Passionate about using technology to improve human health
- 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
- Passion for systems engineering best practices and attention to detail that drives high-quality products
