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

Overview 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 and follow us on LinkedIn: Job Description Our F500 Medical Device client has an exciting opportunity for a Senior Software Engineer. 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. #J-18808-Ljbffr