Systems Engineer - Medical Devices
Job in
New Kensington, Westmoreland County, Pennsylvania, 15068, USA
Listed on 2026-06-26
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-06-26
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
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
- 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
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