workable

Senior or Staff System Engineer

Activ

Boston, USA

Full-time

Senior · 5+ years experience

Hybrid

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Required Qualification
BS/MS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related discipline, with 5+ years of relevant experience
Proven experience producing systems engineering artifacts, including requirements documents, system architecture diagrams, interface control documents (ICDs), and requirements traceability matrices
Experience integrating multi-disciplinary subsystems (hardware, software, optics, AI) into a cohesive, working product
Familiarity with medical device development processes and standards (e.g., IEC 62304, IEC 60601, ISO 13485, ISO 14971)
Experience planning and executing system-level verification and validation activities
Strong analytical and troubleshooting skills, with the ability to debug complex issues that span multiple engineering domains
Excellent communication skills, with the ability to work closely with hardware, software, and clinical teams
Preferred Qualification
Experience in surgical robotics, medical imaging, or another regulated medical device industry
Familiarity with cybersecurity and/or laser technology
Experience with risk management and FMEA processes
Background in optics, computer vision, or embedded systems
Experience supporting design reviews, regulatory submissions, or design history file (DHF) documentation

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