Senior Verification & Validation Engineer - Medical Devices

Sibel Health, Inc.

Chicago (IL)

On-site

USD 110,000 - 160,000

Full time

13 days ago

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Benefits offered by this job

Health insurance
IRA with match
Professional development stipend
Company events & lunches
Flexible time off
Disability insurance

Job summary

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.

Responsibilities

  • 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.

Skills

V&V/test/automation
Regulated industry experience
Medical device experience
Jama Connect / ALM
Automation tooling
AI-assisted test design
Resource leadership
Strong problem solving

Education

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

Tools

Jama Connect

Job description

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

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