Senior System Engineer
soho square solutionsSan Diego (CA)
About the role
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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