Systems Engineer - Medical Devices Only

Intellectt Inc; New Kensington (Westmoreland County); Hybrid; USD 80,000 - 110,000; Full time

Job summary

Intellectt Inc is looking for a Systems Engineer specializing in medical devices to support system architecture, requirements development, and risk management. This is a hybrid position in New Kensington, PA, requiring 3 days onsite per week.

The ideal candidate will have significant experience in Systems Engineering, product development across the lifecycle, and strong knowledge of regulatory standards. The role involves collaboration with cross-functional teams to ensure product success.

Qualifications

• 5+ years of experience in Systems Engineering with a Bachelor's degree or 3+ years with a Master's degree.
• Experience in New Product Development (NPD) lifecycle.
• Hands-on experience with Verification & Validation and Risk Management.

Responsibilities

• Develop system, product, and subsystem requirements.
• Drive requirements traceability, verification, and validation.
• Collaborate with cross-functional engineering team.

Skills

Systems Engineering

Risk Management

Requirements Engineering

Systems Architecture

Electromechanical Systems

Education

Bachelor's or Master's degree in Engineering

Tools

ISO 14971

IEC 60601

Job description

Job Title : Systems Engineer - Medical Devices Only

Location: New Kensington, PA (Hybrid – 3 Days Onsite)

Duration: 11 Months (Possible Extension)

Job Summary

Seeking a Systems Engineer with medical device experience to support system architecture, requirements development, risk management, and product development activities across the full lifecycle

Responsibilities

• Develop system, product, and subsystem requirements
• Interpret and decompose medical device standard
• Perform FMEA and risk management activities
• Drive requirements traceability, verification, and validation
• Develop test plans, protocols, and technical documentation
• Collaborate with cross-functional engineering team

Requirements

• Bachelor's or Master's degree in Engineering or a related fie
• 5+ years of experience (Bachelor's) or 3+ years (Master's) in Systems Engineering, System Design, System Architecture, Hardware Engineering, or Medical Device Product Developme
• Experience across the full New Product Development (NPD) lifecyc
• Strong expertise in electromechanical systems with hardware and software integrati
• on.Hands‑on experience with Requirements Engineering, Verification & Validation, and Risk Management
• Strong knowledge of ISO 14971 and IEC 60601 standard
• Experience with Imaging Devices, Diagnostic Devices, or Patient Monitoring Device
• Strong background in Systems Integration and Systems Architecture
• re.Experience with Product Lifecycle Management (PLM), Regulatory Compliance, and Simulation
• Knowledge of Continuous Improvement practices and CI/CD environment