Sr Hardware Specialist

The Sr Hardware Specialist ensures the reliability, compliance, and lifecycle quality of hardware used in our clinical imaging capture ecosystem by selecting, validating, and sustaining components and configurations; investigating and resolving hardware-related issues from sites and internal stakeholders; and enabling seamless hardware–software integration across our platform. The role partners cross-functionally with Development, Test/QA, Staging/Labs, Product, and Support to deliver fit-for-purpose, validated, and supportable hardware solutions for clinical trials.

Hardware Assessment & Procurement Enablement (25-30%)

• Evaluate and select new components and devices for fitness for use in clinical workflows; document rationale, test evidence, and approved configurations/BOM entries.
• Build and maintain component matrices (e.g., compatibility, lifecycle status, end-of-life (EOL) dates) and alternatives to reduce supply risk.
• Partner with Procurement/Vendor Management to compare vendors on reliability, quality, delivery lead times, and compliance; contribute to vendor scorecards.
• Provide technical specifications and acceptance criteria for purchase; review incoming inspection findings and escalate non-conformances.

Issue Investigation, Root Cause & Reporting (25-30%)

• Triage and investigate site-reported hardware issues; discriminate between hardware defect, configuration drift, environmental factors, or software defect.
• Lead/participate in root cause analysis and drive corrective and preventive actions (CAPA); track through closure.
• Produce clear, reproducible defect documentation and contribute to knowledge articles for Support and field teams.
• Summarize trends and recommend design or process changes to reduce recurrence.

Integration Testing & Validation (25-30%)

• Plan and execute end-to-end hardware–software integration tests, including backward compatibility when introducing new components.
• Author or contribute to validation artifacts aligned to Good Clinical Practice (GCP) and applicable FDA expectations.
• Validate interoperability across cameras/sensors, compute, OS/firmware, drivers, and network/peripherals to assure performance, security, and stability under expected site conditions.

Collaboration & Communication (10-15%)

• Partner closely with Development, Test/QA, Staging/Labs, Product, and Support to ensure smooth introductions of new hardware and changes.
• Provide technical enablement and mentor junior team members on diagnostics and best practices.
• Communicate findings to technical and non-technical audiences; present risk/impact and recommended actions.

Learning & Development (5%)

• Dedicate time to continuous learning, certifications, and staying current with hardware trends and compliance requirements.

Strategic Collaboration (5%)

• Participate in strategic initiatives and cross-functional planning to align hardware roadmap with organizational goals.

Required Experience

• 4 - 6 years of related experience
• (Honors) Bachelor’s degree
• Proven ability to analyze and troubleshoot complex hardware and firmware interactions with a methodical approach, combined with clear validation reports and tracking component compatibility
• Strong understanding of storage interfaces (SATA, NVMe, USB, Thunderbolt) and video I/O protocols (HDMI, SDI, DisplayPort, etc.).
• Experience with video capture devices and equipment including understanding of video technology (compression, encoding, bitrates, frames rate, etc.)
• Experience with hardware diagnostics tools (e.g., SMART, memtest, USB/PCIe analyzers), imaging tools, and log collection utilities.
• Experience with Windows and Linux system configurations.
• Scripting for diagnostics/automation (e.g., Bash, Python, or similar).
• Familiarity with issue tracking systems and knowledge base authoring (Jira, Confluence, ServiceNow, Zendesk, etc.).
• Familiarity with hardware lifecycle management (BOMs, EOL/EOS tracking, supplier alternates) and vendor assessments.
• Exposure to networking fundamentals (wired/wireless, bandwidth/latency considerations) and endpoint security considerations.
• Ability to translate complex technical details into clear, actionable guidance for non-experts.
Preferred Experience:
• Clinical research or regulated environments (e.g., GxP principles, GCP, GMP)
• Experience with medical hardware and clinical trial operations
• Performance tuning and optimization of hardware systems