Senior Software Engineer — Medical Device (Onsite — Irvine, CA) Possible Temp-to-Hire

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

Senior Software Engineer — Medical Device (Onsite — Irvine, CA) Possible Temp-to-Hire

Irvine, United States | Posted on 12/18/2025

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

Our F500 Medical Device client has an exciting opportunity for a Senior Software Engineer.

Job Summary

We are seeking a skilled Senior Software Engineer to join the Client’s Urology team. In this role, you will be responsible for technical activities related to the customization and validation of the Android Operating System (version 5) deployed within a Class III medical device. This role bridges software engineering, cybersecurity, and medical device product integration for a commercial product. The successful candidate will assess, modify, and harden the Android OS to close cybersecurity gaps, adapt critical applications for compatibility, and perform OS-level verification and validation in alignment with regulated product development standards.

This role will work closely with cybersecurity, systems, and quality engineers to ensure system integrity, compliance, and reliable performance of the Android-based platform within the medical device system.

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.

Job Requirements

• 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.

Preferred Qualifications

• Experience with Android OS version 5 or legacy Android platforms in long-lifecycle products.
• Strong debugging, profiling, and reverse‑engineering skills.
• Prior experience supporting device certification and regulatory submissions.
• Excellent communication and documentation skills for technical and compliance deliverables.

Other Details

• Contract Length: 12 Months with possible extension
• Work Set-Up: Hybrid in Arbor Lakes, MN

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.