Senior System Engineer
Soho Square Solutions
We are seeking a Senior Systems Engineer* to lead system-level engineering activities across the product lifecycle, including requirements, risk management, integration, and verification & validation within a regulated product environment.
Responsibilities:
* Lead systems engineering activities from concept through launch and sustaining.
* Develop and manage **system requirements, traceability, and V&V**.
* Lead **system integration, FMEA, hazard analysis, risk assessments, and design reviews**.
* Identify and resolve complex system-level technical issues.
* Collaborate with Software, Electrical, Mechanical, Quality, Regulatory, and Manufacturing teams.
* Support reliability, continuous improvement, and technical risk mitigation.
* Provide technical leadership and mentorship to engineering teams.
Required Skills:
* Bachelor's degree in **Engineering, Science, or related technical field**.
* 3–5+ years** of relevant systems/engineering experience.
* Strong experience with **requirements management and traceability**.
* Hands-on experience with **system-level V&V**.
* Knowledge of **FMEA, hazard analysis, and risk management**.
* Experience with **system integration and cross-functional product development**.
* Strong analytical, communication, technical writing, and problem-solving skills.
Preferred:
* Medical device or regulated industry** experience.
* Experience with software-enabled/connected products.
* Familiarity with **Jama, DOORS, Polarion, MBSE, ISO 14971, or DFSS**.
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