Direct message the job poster from Lumicity
* Lead the development of system-level requirements, architecture, and design for Class II/III medical devices.
* Translate customer and clinical needs into clear, traceable system and sub-system requirements.
* Develop and maintain system architecture models (hardware, software, firmware, and user interfaces).
* Drive system integration activities, ensuring alignment between mechanical, electrical, and software components.
* Conduct risk management activities (FMEA, FTA) and support hazard analysis per ISO 14971.
* Collaborate with cross-functional teams (R&D, Quality, Regulatory, Manufacturing) to ensure system design aligns with design controls (21 CFR Part 11, Part 820, ISO 13485).
* Define and execute verification and validation (V&V) strategies, including test plans and protocols at the system level.
* Contribute to design reviews and technical assessments across product development phases.
* Mentor and support junior engineers in systems engineering best practices.
Qualifications
* Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.
* 5+ years of systems engineering experience in the medical device industry (Class II or III preferred).
* Strong understanding of medical device design controls, risk management (ISO 14971), and regulatory standards (IEC 60601, IEC 62304, ISO 13485).
* Experience with systems modeling tools (SysML, UML, Enterprise Architect, MagicDraw, or similar).
* Proven ability to lead cross-disciplinary technical teams and drive systems integration.
* Excellent analytical, problem-solving, and communication skills.
* Experience with electromechanical and/or software-controlled medical devices is highly desirable.
* Knowledge of human factors engineering and usability standards (IEC 62366) is a plus.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Industries
Medical Equipment Manufacturing
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Pension plan
Paid maternity leave
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