The 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 hardwaresoftware integration across our platform. The role partners crossfunctionally with Development Test/QA Staging/Labs Product and Support to deliver fitforpurpose 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 endoflife (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 nonconformances.
Issue Investigation Root Cause & Reporting (25-30%)
- Triage and investigate sitereported 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 endtoend hardwaresoftware 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 nontechnical 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) Bachelors 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 nonexperts.
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.
Required Experience:
IC
The 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; ...
The 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 hardwaresoftware integration across our platform. The role partners crossfunctionally with Development Test/QA Staging/Labs Product and Support to deliver fitforpurpose 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 endoflife (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 nonconformances.
Issue Investigation Root Cause & Reporting (25-30%)
- Triage and investigate sitereported 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 endtoend hardwaresoftware 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 nontechnical 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) Bachelors 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 nonexperts.
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.
Required Experience:
IC
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