Pharmavise Corporation

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

Pharmavise Corporation  •  Irvine, CA (Hybrid)  •  5 months ago
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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:
• Schedule: 08:00:AM - 04:30:PM
• Contract Length: 12 Months with possible extension
• Work Set-Up: Hybrid in Arbor Lakes, MN
• Start Date: 1/5/2026
Pharmavise Corporation

About Pharmavise Corporation

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.

𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:

We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.

𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:

☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.

☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.

☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.

𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆

Over 20 Technical Transfers and 30 product launches.

11 FDA remediations. Warning Letters and or Consent Decrees.

Cost savings and increased efficiency of over 10MM for clients

Industry
Consulting & Advisory
Company Size
11-50 employees
Headquarters
Fort Lauderdale, Florida
Year Founded
2013
Website
pharmavise.com
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