Senior Systems Engineer (Software & Hardware Integration)

Description

We are seeking a highly experienced Senior Systems Engineer with a strong background in medical device development. This individual will play a critical role in defining, owning, and elevating systems engineering practices across multiple programs, with a focus on requirements, risk management, and cross-functional integration across software, electrical, and mechanical domains.

This is a hands-on, senior-level role for someone who can independently drive systems work from day one, while also mentoring other engineers and raising the bar for systems rigor—particularly in requirements development, risk assessment, and design controls.

Key Responsibilities

• Lead the development, decomposition, and management of product and system requirements, ensuring clarity, completeness, and traceability (Jama, Polarion)
• Translate product and clinical needs into well-defined system and subsystem requirements across software, electrical (PCBA), and mechanical components
• Own and drive system-level risk management activities, including hazard analysis, FMEA, and risk mitigation strategies—particularly for electromechanical and electrical risks (e.g., leakage, power delivery)
• Partner cross-functionally with software, electrical, mechanical, and firmware teams to ensure proper system integration and interface definition
• Support and guide system architecture and design decisions, ensuring alignment across subsystems
• Lead and support verification and validation efforts, including defining test strategies and ensuring requirements are fully testable
• Contribute to and review hardware testing efforts, including circuit board (PCBA) testing, data collection, and analysis to inform design and risk decisions
• Ensure all development activities align with FDA regulations, medical device design controls, and applicable standards
• Mentor and support junior and mid-level systems engineers, helping elevate best practices in requirements and risk management

Qualifications

• Extensive Systems Engineering experience within the medical device industry
• Proven ability to independently develop high-quality product and system requirements and drive them through the full lifecycle
• Strong experience interfacing across software, electrical (PCBA), mechanical, and firmware teams
• Deep understanding of risk management processes, including FMEA, hazard analysis, and mitigation of electromechanical and electrical risks (e.g., leakage current, energy delivery)
• Experience supporting hardware development, including circuit design, testing, verification, and data analysis
• Familiarity with RF or energy-based systems is a strong plus
• Experience with requirements management tools such as Jama or Polarion
• Strong knowledge of FDA regulations, IEC standards, and medical device design controls