Senior Verification & Validation Engineer - Medical Devices

Sibel Health, Inc.; Chicago (IL); Sur place; USD 110 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health insurance

IRA with match

Professional development stipend

Company events & lunches

Flexible time off

Disability insurance

Résumé du poste

Sibel Health, Inc. in Chicago, IL is seeking a Senior Verification & Validation Engineer to lead verification planning and execution for wearables and clinical monitoring systems.

You will review requirements, craft test strategies, develop protocols, and manage reports to ensure safety and performance. You will mentor contract and offshore test resources, collaborate across Design Engineering, Product Management, and Quality/Regulatory teams, and help grow the V&V function in an Agile

Qualifications

• Bachelor’s degree in biomedical engineering, electrical engineering (SW/EE), computer science, or related field.
• 5+ years experience in verification/V&V/test/automation engineering.
• Experience in a regulated industry is required.
• Medical device experience (Class II/IIb) preferred; familiarity with 21 CFR 820 / EU MDR.

Responsabilités

• Plan and manage verification activities across multiple projects.
• Review requirements and design docs for verifiability.
• Translate requirements into verification protocols.
• Define system-level verification strategies across milestones.
• Own Jama Connect traceability and gap closure.
• Lead anomaly investigations and regression planning.
• Collaborate with cross-functional teams in an Agile setting.

Connaissances

V&V/test/automation

Regulated industry experience

Medical device experience

Jama Connect / ALM

Automation tooling

AI-assisted test design

Resource leadership

Strong problem solving

Formation

Bachelor's degree in biomedical engineering, electrical engineering (SW/EE), computer science, or related field

Outils

Jama Connect

Description du poste

Sibel Health, Inc. in Chicago, IL is seeking a Senior Verification & Validation Engineer to lead verification planning and execution for wearables and clinical monitoring systems.

You will review requirements, craft test strategies, develop protocols, and manage reports to ensure safety and performance. You will mentor contract and offshore test resources, collaborate across Design Engineering, Product Management, and Quality/Regulatory teams, and help grow the V&V function in an Agile