Medium
Overview
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 toanalyze and troubleshootcomplex hardware and firmware interactions with a methodical approach, combined with clear validation reports and tracking component compatibility
- Strong understanding ofstorage interfaces(SATA, NVMe, USB, Thunderbolt) andvideo 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 withWindows and Linuxsystem configurations.
- Scripting for diagnostics/automation (e.g., Bash, Python, or similar).
- Familiarity withissue tracking systemsandknowledge baseauthoring (Jira, Confluence, ServiceNow, Zendesk, etc.).
- Familiarity withhardware lifecycle management(BOMs, EOL/EOS tracking, supplier alternates) andvendor assessments.
- Exposure tonetworking fundamentals(wired/wireless, bandwidth/latency considerations) andendpoint securityconsiderations.
- Ability totranslate complex technical detailsinto 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