Senior Software Engineer — Medical Device (Onsite — Irvine, CA) Possible Temp\-to\-Hire jobs in United States
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Pharmavise Corporation · 3 weeks ago

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

positionIrvine, California, United States
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

Pharmavise Corporation is seeking a skilled Senior Software Engineer to join the Client’s Urology team. This role involves technical activities related to the customization and validation of the Android Operating System within a Class III medical device, bridging software engineering, cybersecurity, and medical device product integration.

Food and BeverageHealth Care

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

Qualification

Android OS developmentAOSPEmbedded systemsRegulated environmentsLinux internalsCybersecurity risk assessmentIEC 62304ISO 14971Debugging skillsCommunication skills

Required

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

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

Company

Pharmavise Corporation

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♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.
dateFounded in 2013
location
Coral Springs, Florida, USA
people-size11-50 employees
web-link
http://www.pharmavise.com

Funding

Current Stage
Early Stage
Total Funding
unknown
2020-04-04Seed

Leadership Team

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Ricardo Joseph
Founder and CEO
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Company data provided by crunchbase