seeking a talented and motivated Systems Design Engineer to join our dynamic team. The successful candidate will be responsible for designing, developing, and optimizing complex medical device systems. This role requires a strong understanding of engineering principles, medical device regulations, and cross-functional collaboration.

Key Responsibilities:

• Design and develop medical device systems, ensuring compliance with regulatory standards (e.g., FDA, ISO).
• Collaborate with cross-functional teams, including mechanical, electrical, and software engineers, to integrate system components.
• Conduct system-level analysis and testing to ensure performance, reliability, and safety.
• Create and maintain detailed design documentation, including specifications, schematics, and test plans.
• Participate in risk management activities, including FMEA and hazard analysis.
• Support the verification and validation process, including test protocol development and execution.
• Troubleshoot and resolve system-level issues during development and post-market phases.
• Stay current with industry trends, technologies, and regulatory changes.

Qualifications:

• Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related field.
• 3+ years of experience in systems design, preferably in the medical device industry.
• Strong knowledge of medical device regulations and standards (e.g., FDA, ISO 13485).
• Proficiency in systems engineering tools and methodologies (e.g., SysML, MATLAB, Simulink).
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork abilities.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Preferred Qualifications:

• Experience with embedded systems and software development.
• Knowledge of human factors engineering and usability testing.
• Familiarity with quality management systems (QMS) and design control processes.