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.
