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

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.