Verification & Validation (V&V) Engineer – Medical Devices

Stark Pharma Solutions Inc; Bellevue (WA); On-site; USD 110,000 - 140,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Verification & Validation (V&V) Engineer to support development and testing of next-generation connected medical devices.

This role will focus on system-level verification and validation across wearable devices, embedded software, mobile applications, cloud platforms, and data pipelines, ensuring products meet regulatory, quality, and performance requirements.

Qualifications

• Bachelor's or Master's degree in Electrical, Biomedical, Computer, or Systems Engineering (or related field).
• 5–8+ years of Verification & Validation or Systems Engineering experience within the Medical Device industry.
• Experience with connected medical devices involving hardware, embedded software, mobile applications, and cloud platforms.
• Strong knowledge of system integration, requirements management, risk analysis, and V&V methodologies.
• Experience developing test plans, protocols, functional test procedures, and validation documentation.
• Familiarity with medical device regulations and quality systems.
• Strong troubleshooting, analytical, and cross-functional collaboration skills.

Responsibilities

• Develop and execute system-level Verification & Validation (V&V) plans, protocols, and reports.
• Lead integration planning and testing across wearable devices, embedded systems, mobile applications, cloud platforms, and user portals.
• Perform system verification for functionality, performance, reliability, safety, and cybersecurity.
• Develop risk analyses, system models, and mitigation strategies throughout the product lifecycle.
• Collaborate with hardware, software, and systems engineering teams to troubleshoot and resolve integration issues.
• Support requirements management, traceability, and compliance with medical device quality standards.
• Apply systems engineering best practices throughout product development.

Skills

V&V experience

Systems engineering

Regulatory knowledge

Requirements management

Risk analysis

Test planning

Quality systems

Cross-functional collaboration

Embedded software

Education

Bachelor's or Master's degree in Electrical, Biomedical, Computer, or Systems Engineering

Job description

Role: Verification & Validation (V&V) Engineer Medical Devices

Location: Bellevue, WA (Onsite)

Duration: 12 Months

Experience: 5 8 Years

Job Overview

We are seeking an experienced Verification & Validation (V&V) Engineer to support the development and testing of next‑generation connected medical devices. This role will focus on system‑level verification and validation across wearable devices, embedded software, mobile applications, cloud platforms, and data pipelines, ensuring products meet regulatory, quality, and performance requirements.

Key Responsibilities

• Develop and execute system‑level Verification & Validation (V&V) plans, protocols, and reports.
• Lead integration planning and testing across wearable devices, embedded systems, mobile applications, cloud platforms, and user portals.
• Perform system verification for functionality, performance, reliability, safety, and cybersecurity.
• Develop risk analyses, system models, and mitigation strategies throughout the product lifecycle.
• Collaborate with hardware, software, and systems engineering teams to troubleshoot and resolve integration issues.
• Support requirements management, traceability, and compliance with medical device quality standards.
• Apply systems engineering best practices throughout product development.

Required Qualifications

• Bachelor's or Master's degree in Electrical, Biomedical, Computer, or Systems Engineering (or related field).
• 5 8+ years of Verification & Validation or Systems Engineering experience within the Medical Device industry.
• Experience with connected medical devices involving hardware, embedded software, mobile applications, and cloud platforms.
• Strong knowledge of system integration, requirements management, risk analysis, and V&V methodologies.
• Experience developing test plans, protocols, functional test procedures, and validation documentation.
• Familiarity with medical device regulations and quality systems.
• Strong troubleshooting, analytical, and cross‑functional collaboration skills.