Senior Hardware Platform & Systems Integration Engineer

We are seeking a Senior Hardware Platform & Systems Integration Engineer with strong experience integrating commercial off-the-shelf (COTS) computing platforms into regulated medical devices. This individual will play a key role in evaluating, integrating, troubleshooting, and optimizing hardware platforms that support real-time medical image processing and AI applications deployed in both cloud-connected and on-premises environments., * Lead the evaluation, selection, and integration of commercial off-the-shelf (COTS) hardware platforms, including motherboards, CPUs, GPUs, memory, storage, networking, and peripheral components.

• Support the development and evolution of next-generation hardware platforms for AI-enabled medical systems.
• Investigate and resolve complex hardware-related issues, , GPU compatibility, storage reliability, thermal performance, power stability, and system integration challenges.
• Work closely with software, AI, systems, manufacturing, and quality engineering teams to ensure seamless hardware and software integration.
• Evaluate and optimize Windows-based embedded platforms supporting both cloud-connected and on-premises AI deployments.
• Collaborate with hardware suppliers and OEMs to evaluate new technologies, qualify alternate components, and manage hardware lifecycle and obsolescence.
• Develop and execute hardware verification, integration, and reliability testing to support product development and manufacturing.
• Perform root cause investigations for field and manufacturing issues and drive corrective and preventive actions.
• Support product cost optimization, manufacturability improvements, and long-term hardware platform sustainability.
• Participate in design reviews, risk management activities, and engineering documentation supporting regulated medical device development.
• Present technical recommendations, project updates, and hardware improvement strategies to cross-functional teams and leadership.

The ideal candidate has a strong systems engineering mindset and understands the interaction between hardware, operating systems, networking, GPUs, and software applications. This role focuses on hardware platform architecture, supplier collaboration, reliability improvements, and lifecycle management rather than custom electronic circuit design., * 5+ years of experience developing, integrating, or supporting embedded computing platforms, industrial PCs, or medical device hardware.

• Experience integrating commercial off-the-shelf (COTS) computer hardware into production products.
• Strong understanding of embedded computer architecture, including CPUs, GPUs, motherboards, PCIe, storage, memory, networking, and peripheral interfaces.
• Experience with Windows-based embedded systems, Windows IoT, and hardware/software integration.
• Proven experience troubleshooting complex hardware failures and performing root cause analysis.
• Experience working directly with hardware vendors, OEMs, and component suppliers.
• Knowledge of hardware qualification, verification, validation, and reliability testing methodologies.
• Experience supporting products throughout the full product lifecycle, including development, manufacturing, field support, and component obsolescence.
• Working knowledge of medical device design controls, risk management, and regulated product development.
• Familiarity with FDA Quality System Regulation, ISO 13485, ISO 14971, IEC 62304, and IEC 81001-5-1 is preferred.
• Excellent communication, analytical, and cross-functional collaboration skills with the ability to work effectively across multidisciplinary engineering teams.

Pulled from the full job description

• Professional development assistance
• Tuition reimbursement
• 401(k)
• Health insurance
• Retirement plan
• 401(k) matching
• Paid time off, * The opportunity to make an immediate and visible impact in a fast-growing company
• 401(k) with employer matching at 3 months of employment
• 3 weeks of PTO on per calendar year
• 13 paid holidays
• Medical, Dental and Vision insurance

Pay: $135,000.00 - $170,000.00 per year, * 401(k)

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement

Company Description Warwick Consulting, founded in 2011, is a specialized medical device consulting firm focused on non-compliance remediation, software assurance, cybersecurity, SaMD, R&D, and verification & validation. The company helps clients navigate complex regulatory requirements while ensuring medical device quality, security, and reliability. Warwick Consulting operates as a seamless extension of client teams, providing integrated support across all phases of medical device development. The firm serves a diverse client base, from Fortune 500 organizations to early-stage startups, and has supported the development and commercial success of over 35 medical devices. With more than 300 Design History Files across 25+ therapeutic areas, Warwick Consulting is a trusted partner in medical device innovation.