Principal Systems Engineer - Medical Devices

Stark Pharma; Bellevue (WA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma in Bellevue, WA is seeking a Principal Systems Engineer to lead the development of connected medical device technologies. This role emphasizes system integration, verification, and validation while ensuring data reliability in both hardware and software environments.

The ideal candidate boasts 5-8 years of Systems Engineering experience, particularly in regulated industries, and will work closely with cross-functional teams. The position offers a hybrid work model, balancing remote and onsite engagement.

Qualifications

• Bachelor's or Master's degree in Electrical, Biomedical, Computer, or Systems Engineering.
• 5-8 years of experience in systems engineering for connected medical devices.
• Expertise in hardware/software integration and product lifecycle development.

Responsibilities

• Lead integration planning and testing for medical devices.
• Develop system-level V&V strategies and protocols.
• Perform hazard analysis and reliability assessments.
• Collaborate with Hardware, Software, and Regulatory teams.
• Support troubleshooting of hardware/software integration issues.

Skills

Systems Engineering

Risk Management

Verification & Validation

Data Reliability

Cross-functional Collaboration

Education

Bachelor's or Master's in Engineering

Electrical Engineering

Biomedical Engineering

Computer Engineering

Systems Engineering

Job description

Job Title: Principal Systems Engineer - Medical Devices

Location: Bellevue, WA (Hybrid Flexible Remote/Onsite Schedule)

Contract Duration: 12 Months

Work Schedule: Standard hours 8:00 AM - 5:00 PM (flexibility required based on project needs)

Job Summary

We are seeking a Principal Systems Engineer to support the development and integration of connected medical device technologies within a hybrid hardware/software ecosystem. This role will focus on system integration, verification & validation, data reliability, and end-to-end product performance across wearable devices, mobile applications, cloud platforms, and digital health systems.

The ideal candidate will have strong experience in systems engineering for connected medical devices, with expertise in integrated hardware/software environments, risk management, and product lifecycle development within regulated industries.

Key Responsibilities

• Lead integration planning and testing activities across wearable devices, mobile applications, cloud software, algorithms, and user-facing platforms
• Develop and execute system‑level Verification & Validation (V&V) strategies, protocols, and reports
• Perform systems modeling, hazard analysis, risk mitigation, and reliability assessments
• Analyze system performance, data flow, integrity, and reliability across end‑to‑end data pipelines
• Collaborate cross‑functionally with Hardware, Software, Cloud, Quality, and Regulatory teams throughout product development
• Support system troubleshooting, debugging, and root cause analysis related to hardware/software integration issues
• Contribute to design reviews, technical documentation, compliance activities, and engineering best practices
• Apply systems engineering methodologies and product development standards within regulated medical device environments

Required Qualifications

Degree: Bachelor s or Master s in one of the following (related discipline)

• Electrical Engineering
• Biomedical Engineering
• Computer Engineering
• Systems Engineering
• Related technical discipline

Experience: 5 8+ years of Systems Engineering experience supporting:

• Connected medical devices
• Hardware/software integrated systems
• Digital health or end-to-end product ecosystems