More jobs:
Systems Engineer
Job in
New Kensington, Westmoreland County, Pennsylvania, 15068, USA
Listed on 2026-07-07
Listing for:
Intellectt INC
Full Time
position Listed on 2026-07-07
Job specializations:
-
Engineering
Systems Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title:
System Engineer
Location:
New Kensington, PA (Hybrid 3 days onsite)
Duration: 11 Months
Seeking an experienced Systems Engineer to support the development of medical devices from concept through product release. The role focuses on requirements engineering, risk management, systems design, medical device standards, and cross‑functional leadership.
Key Responsibilities- Define and manage product, system, and subsystem requirements.
- Develop system architecture and design specifications.
- Interpret medical device standards (IEC 60601, ISO 80601, ISO 14971) and translate them into product requirements.
- Lead risk analysis and FMEA activities.
- Create and maintain Risk Management Files (RMF) and Design History Files (DHF).
- Develop requirements traceability matrices throughout the V‑model lifecycle.
- Create Verification & Validation (V&V) plans, protocols, and test strategies.
- Collaborate with R&D, Manufacturing, Quality, Software, Hardware, and Regulatory teams.
- Lead technical reviews and mentor junior engineers.
- Support New Product Development (NPD) through the full product lifecycle.
- Systems Engineering
- Systems Architecture
- Requirements Analysis
- Risk Management & FMEA
- Product Lifecycle Management
- Systems Integration
- Regulatory Compliance
- V&V Planning
- Traceability Management
- Continuous Improvement
For more information, please reach out at or share your updated resume with
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