System Engineer
Job in
New Kensington, Westmoreland County, Pennsylvania, 15068, USA
Listed on 2026-06-20
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-06-20
Job specializations:
-
Engineering
Systems Engineer, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
Job Overview
This role focuses on systems engineering activities supporting the development of electromechanical medical devices, including requirements management, risk analysis, verification planning, and cross-functional collaboration throughout the product lifecycle.
Core Responsibilities- Systems Engineering & System Architecture
- Product & Element Requirements Development
- Requirements Traceability & V-Model Execution
- FMEA, Risk Assessments & ISO 14971
- Design History File (DHF) & Risk Management File
- Electromechanical Systems (Hardware + Software Integration)
- Cross-Functional Technical Reviews & Collaboration
Responsibilities include developing and decomposing requirements, conducting FMEA activities, maintaining risk and design documentation, developing V&V protocols and traceability matrices, leading technical reviews, and ensuring compliance with medical device standards throughout the development process.
Key Qualifications- Bachelor's/Master's in Electrical, Electronics, Mechanical, Computer Science Engineering, or equivalent
- Experience across the full product development lifecycle
- Familiarity with FDA-regulated environments and medical device compliance
- CSEP Certification is a plus
- Experience working with multidisciplinary teams across R&D, Manufacturing, Quality, and Regulatory Affairs
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