Senior System Engineer

Senior Systems Engineer serves as a technical lead supporting the design and development of innovative wearable medical devices, including connected cloud and data management systems. This role leads systems engineering activities across the full product lifecycle, collaborating with cross‑functional teams to deliver compliant, high‑quality medical device solutions in a regulated environment.

• Lead systems engineering efforts for new and existing product development programs, from concept through commercialization.
• Define system and subsystem architectures, user needs, requirements, and use cases.
• Identify system hazards, failure modes, and risk mitigations in alignment with regulatory standards.
• Collaborate with cross‑functional teams and suppliers to assess, integrate, and qualify components and subsystems.
• Support integration, verification, and validation activities, including creation of plans, protocols, and reports.
• Maintain full design traceability across requirements, design outputs, verification/validation, and risk management artifacts.
• Serve as a technical consultant for software development and participate in Agile ceremonies.
• Provide technical leadership, project planning support, and mentoring to junior engineers.

• Bachelor’s degree in Systems, Biomedical, Electrical, Mechanical, Computer Science, or related engineering discipline.
• 3–7+ years of systems engineering experience in a multidisciplinary, regulated product development environment, including 2+ years in a technical leadership role.
• Strong expertise in systems engineering practices, requirements management, risk analysis, and verification planning.
• Experience with ALM/PLM tools (e.g., Polarion, DOORS, Helix, Arena) and data analysis tools (e.g., MATLAB, JMP, Minitab).
• Knowledge of medical device regulations and design controls (ISO 13485, ISO 14971, IEC 62304, 21 CFR 820).
• Familiarity with Agile development, cloud technologies, and connected device systems preferred.

Seniority level:
Mid‑Senior level

Employment type:

Contract

Job function:
Information Technology

Industry: Medical Equipment Manufacturing

Inferred benefits:

• Medical insurance
• Vision insurance
• 401(k)