Senior Systems Design Engineer
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.
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