Senior Android OS Engineer — Medical Device (Irvine)

Pharmavise Corporation; Irvine (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Pharmavise Corporation is seeking a Senior Software Engineer to customize and harden an Android OS (v5) for a Class III medical device, with responsibilities spanning cybersecurity, OS-level validation, and regulatory alignment.

You will work on integrating third‑party libraries, adapting apps for the OS, and ensuring compliance with IEC 62304, ISO 14971, and related standards within a regulated environment.

Qualifications

• Bachelor’s or Master’s degree in computer engineering, computer science, electrical engineering, or a related field.
• 7+ years of professional software engineering experience, with at least 3 years in Android OS development or customization.
• Hands-on experience with AOSP, Android build systems, and kernel-level modification.
• Strong understanding of embedded systems, Linux internals, and Android application frameworks.
• Proven experience in regulated environments (medical device, aerospace, automotive, or defense).
• Working knowledge of IEC 62304, ISO 14971, IEC 60601, and other regulations.
• Familiarity with cybersecurity risk assessment, threat modeling, and vulnerability remediation in embedded platforms.

Responsibilities

• Analyze and modify Android OS (v5) source to address identified cybersecurity vulnerabilities and compliance gaps.
• Implement OS-level patches, configuration changes, and security controls consistent with medical device cybersecurity guidance (FDA premarket & post market cybersecurity, and EU MDCG).
• Manage integration of third-party libraries and drivers while maintaining software traceability and regulatory documentation.
• Adapt and refactor existing applications to ensure compatibility with the custom Android OS as needed.
• Optimize interprocess communication, resource management, and hardware interface behaviors in the updated OS environment.
• Collaborate with application developers to test and validate functionality per intended use.
• Conduct OS-level verification and validation per IEC 62304 and internal design control SOPs
• Support risk analysis and mitigation activities per ISO 14971 and internal software QMS SOPs.
• Contribute to software documentation, including software architecture, verification plans, test protocols, and traceability matrices.
• Participate in technical reviews and audits to ensure software compliance with applicable standards.
• Work in close coordination with cybersecurity, software, design quality, and system engineering teams to ensure secure and reliable system operation.
• Support integration testing and root cause analysis of OS-related issues.

Skills

Android OS development

AOSP / Android build systems

Kernel-level modification

Embedded systems

Linux internals

Android app frameworks

Regulated environments

IEC 62304 / ISO 14971 knowledge

Cybersecurity risk assessment

Education

Bachelor’s or Master’s degree in a related field

Job description

Pharmavise Corporation is seeking a Senior Software Engineer to customize and harden an Android OS (v5) for a Class III medical device, with responsibilities spanning cybersecurity, OS-level validation, and regulatory alignment.

You will work on integrating third‑party libraries, adapting apps for the OS, and ensuring compliance with IEC 62304, ISO 14971, and related standards within a regulated environment.