Description

Lead systems integration, verification, and validation for end-to-end medical device ecosystems spanning wearables, mobile apps, and cloud infrastructure.

This role is hybrid.

Responsibilities

• Evaluate integration points and lead planning for wearable devices, mobile applications, software algorithms, and user portals.
• Develop and execute comprehensive test plans to verify system performance, safety, and security across the entire ecosystem.
• Create system models, risk analyses, and mitigation strategies to address unique component challenges.
• Analyze system performance, reliability, and data integrity across the data pipeline from device collection to cloud storage.
• Act as subject matter expert for applying systems engineering standards to product development processes.

Required Skills

• 5–8+ years of experience in systems engineering, focusing on connected medical devices or complex hardware-software integration.
• Proven expertise in systems modeling, requirements management, risk analysis, and V&V practices.
• Strong understanding of medical device regulations, quality systems, and data privacy standards.
• Broad technical knowledge of embedded systems, sensors, algorithms, cloud applications, and data engineering.
• Experience developing system design verification plans and functional test procedures.
• Programming and scripting skills in Python and RESTful APIs.
• Bachelor’s or Master’s degree in Electrical, Biomedical, Computer Engineering, Systems Engineering, or related technical discipline.

Preferred Skills

• Intermediate knowledge of electro-mechanical hardware qualification and statistics.
• Familiarity with Azure DevOps (ADO) or similar CI/CD tools.
• Knowledge of CAD and design/version control requirement tools.

Key Skills

Education

Bachelor's or Master's degrees