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Senior Verification & Validation Engineer

Full-Time

$105k - $135k/yr

Chicago, IL, USA

Full-Time

Senior Verification & Validation Engineer

Confirmed live in the last 24 hours

Sibel Health

Sibel Health

51-200 employees

Develops advanced medical monitoring sensors

Compensation Overview

$105k - $135k/yr

Senior

No H1B Sponsorship

Chicago, IL, USA

Must be a resident or be willing to relocate to Chicago, IL.

Category
QA & Testing
Automation Testing
Quality Assurance
Required Skills
Agile
Python
C/C++
Connection
Connection
Connection
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Requirements
  • Bachelor's degree in engineering, computer science, or a related technical field.
  • 5+ years experience in verification/V&V/tester/automation engineering or similar role.
  • Experience in regulated industry, medical device industry is preferred.
  • Knowledge in system-level design, requirements management, and V&V processes and tools.
  • Solid understanding of medical device regulations and standards (e.g., FDA QSR, ISO 13485, IEC 60601).
  • Experience in automation tools and platforms is preferred.
  • Strong problem solving skills, detail oriented, with a passion to drive product quality through user-centered testing.
  • Self-motivated and can effectively adapt and prioritize multiple projects/tasks while meeting expected deadlines.
  • Must be a resident or be willing to relocate to Chicago, IL.
Responsibilities
  • Planning and managing the verification activities for multiple projects, coordinating with project management on verification timelines, deliverables, and readiness.
  • Experience reviewing and examining requirements, interface specifications, UI/ID specifications, and technical design documents.
  • Ability to translate requirements and design documents into verification protocols, taking into account both technical design and clinical use cases.
  • Defining and implementing test strategies and methodologies for multiple projects.
  • Performing manual and automated testing and analysis to identify and document any anomalies.
  • Developing and maintaining automated test scripts using appropriate tools and languages (e.g., Python, C++, test frameworks).
  • Maintaining accurate and complete documentation of all verification activities, including verification plans, verification reports, and anomalies reports.
  • Responsible for overseeing the various validation activities, working closely with Product Management, to ensure they are completed in accordance with the V&V Plan.
  • Pro-actively collaborating with other groups including Systems Engineering, UI Designers, Product Management, and the Engineering teams (SW, HW, FW, Algorithm).
  • Working within an Agile team environment, supporting in-sprint verification activities and planning.
Desired Qualifications
  • Experience in regulated industry, medical device industry is preferred.
  • Experience in automation tools and platforms is preferred.

Sibel Health focuses on enhancing patient care through advanced medical monitoring solutions. Its main product, the ADAM sensor, captures detailed physiological data using features like a three-axis accelerometer, gyroscope, temperature sensor, and Bluetooth Low Energy connectivity, all within a waterproof silicone casing. The sensor is designed for single-use and adheres gently to the skin for continuous monitoring. Sibel Health serves healthcare providers, clinical researchers, and hospitals, offering FDA-cleared devices that meet strict regulatory standards. The company generates revenue from sensor sales and data insights that aid clinical decision-making. Sibel Health's goal is to provide accurate health data to improve patient outcomes in both clinical settings and everyday medical care.

Company Size

51-200

Company Stage

Series C

Total Funding

$82.8M

Headquarters

Evanston, Illinois

Founded

2018

Simplify Jobs

Simplify's Take

What believers are saying

  • Sibel Health secured $30M in Series C funding to expand operations and R&D.
  • The Gates Foundation grant supports expansion of maternal monitoring in low-income countries.
  • Collaboration with Medidata enhances clinical trial data collection and analysis capabilities.

What critics are saying

  • Increased competition from emerging startups threatens Sibel Health's market share.
  • Reliance on FDA clearances could delay product launches and market entry.
  • Global economic downturn may limit adoption of Sibel Health's monitoring systems.

What makes Sibel Health unique

  • Sibel Health's ADAM sensor offers advanced features like a three-axis accelerometer and gyroscope.
  • The ANNE One platform complies with IEEE SDC 11073, ensuring device interoperability.
  • Sibel Health's FDA-cleared devices meet stringent regulatory standards, enhancing trust and adoption.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Company Match

Professional Development Budget

Unlimited Paid Time Off

Company Social Events

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

8%
Bizjournals
Mar 21st, 2025
The Beat: Sibel Health secures major funding boost

Sibel Health announced Thursday that it has closed on $30M in Series C funding led by the Steele Foundation for Hope with significant participation by Dräger.

Webrazzi
Mar 21st, 2025
Sibel Health secures $30M Series C funding

Sibel Health, a remote patient monitoring startup, secured $30 million in a Series C funding round led by Steele Foundation for Hope, with participation from Dräger. Previously, in August 2022, the company received $33 million from the same foundation. Sibel Health also received a $17.5 million grant from the Bill & Melinda Gates Foundation. The new funds will be used to expand operations and advance R&D.

Our Health Needs
Mar 20th, 2025
Sibel Health secures $30M, seventh FDA clearance

Patient monitoring company Sibel Health, a spin-out of Northwestern University, closed a $30 million Series C equity financing round and received its seventh FDA clearance.

Finsmes
Mar 20th, 2025
Sibel Health Closes $30M Series C Financing

Sibel Health closes $30M Series C financing.

PR Newswire
Mar 20th, 2025
Sibel Health Announces Close Of New Series C Financing And New Fda 510(K) Clearance

Enabled by advanced clinical-grade wearable sensors, the ANNE® One platform offers wireless monitoring of all vital signs for patients 12 years and older. This financing is timed to Sibel's newest FDA 510(k) clearance enabling alarms and alerts along with a powerful central station. "We are especially proud of the fact that our sensors are FDA-cleared under the IEEE SDC 11073 standard, which supports open and secure communication between medical devices replacing traditional proprietary networks. Interoperability is the future and our hospital partners are increasingly demanding it," notes Jong Yoon Lee, CTO and cofounder of Sibel Health. The ANNE® One platform is one of the first medical devices to receive FDA-clearance following the IEEE SDC 11073 standard. "Without interoperability of medical devices, particularly vital signs monitors like ours, we cannot capture the broader care context and realize the full potential of AI to detect patient deterioration earlier," adds Steve Xu MD