Job Title: Systems Engineering Manager

Work Location: Massachusetts

Summary:

Seeking a Systems Engineering Manager to lead the integration of hardware, software, and clinical requirements into a cohesive, high-performance platform for advanced cardiac electrophysiology diagnostic systems. The role involves managing a multidisciplinary engineering team and ensuring the development of a scalable and compliant system architecture.

Responsibilities:

• Strategic Leadership: Manage and mentor a multidisciplinary team of engineers, fostering a culture of technical excellence and rigorous problem-solving.
• Lifecycle Oversight: Drive the end-to-end system development lifecycle, from initial concept and requirements definition to final system verification and clinical validation.
• Cross-Functional Synergy: Act as the primary technical bridge between R&D, Product Management, and Quality Assurance to ensure all subsystems align with the overarching product vision.
• Risk & Compliance Management: Oversee system-level risk analysis (FMEA) and ensure all engineering activities adhere to ISO 14971 and relevant FDA/CE regulatory frameworks.
• Technical Roadmap: Define and maintain the system architecture strategy, ensuring the platform is scalable, maintainable, and capable of integrating future technological breakthroughs.

Qualifications:

• Engineering Background: Extensive experience in systems engineering for complex, high-stakes environments (Medical Device, Aerospace, or Robotics).
• Technical Breadth: Strong understanding of the interplay between embedded software, complex sensor hardware, and digital signal processing.
• Regulatory Knowledge: Deep familiarity with Class II/III medical device standards (such as IEC 60601 and ISO 13485).
• Leadership Provenance: A track record of leading technical teams through successful product launches or significant version iterations.
• Education: BS/MS in Systems Engineering, Electrical Engineering, Biomedical Engineering, or a related discipline.

Published Category: Manufacturing & Technical Operations