Senior V&V Engineer - Medical Devices & Connected Systems

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

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.