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Systems Engineering Manager
Not specifiedFull-timeSystems IntegrationMedical Devices
Lead a team of Systems Engineers responsible for system and hardware requirements, algorithm development, modeling and simulation, hardware-software integration, and validation across the product development lifecycle. Serve as Agile Product Owner and coordinate with R&D, Quality, Regulatory Affairs
Responsibilities
- Lead system and hardware requirements definition, maintenance, review, approval, change management, and traceability
- Establish algorithm development practices and own algorithm requirements, performance specifications, acceptance criteria, and traceability
- Lead development of proprietary algorithms and methods for verification, validation, and performance characterization
- Oversee proof-of-design activities and support intellectual property and innovation initiatives
- Lead system modeling and simulation for design decisions, predictive analysis, risk assessment, and optimization
- Define hardware-software integration strategies, lead integration activities and issue resolution, and manage interface risks
- Lead, coach, and develop Systems Engineers, including performance and career development
- Serve as Agile Product Owner, managing priorities, backlog, and sprint objectives
- Collaborate with R&D, Quality, Regulatory Affairs, Clinical, and Program Management to align requirements, design, verification, and project goals
- Promote modern systems engineering, model-based and data-driven practices, and appropriate use of AI-enabled tools
Requirements
- At least 8 years of experience as a systems, integration, hardware, software, mechanical, or biomedical engineer
- At least 3 years of Systems Engineering experience in a medical device company
- Experience developing signal-processing, control, imaging, data-analysis, or optimization algorithms
- Experience with modeling and simulation environments
- Strong statistical and analytical skills
- Experience translating clinical or user needs into quantitative performance requirements
- Knowledge of Design Controls, IEC 62304, IEC 60601, ISO 14971, and applicable medical device regulations
- Experience in Agile and hybrid product development environments
- Experience with requirements management and traceability tools and methodologies
- Familiarity with quality management systems, design controls, and risk management in regulated medical device environments
- Advanced degree in Engineering, Physics, Applied Mathematics, Computer Science, or a related field preferred
Nice to have
- Previous leadership, project leadership, or people management experience, including military experience
- Experience developing in Agile environments