Systems Engineering Role
We are seeking an experienced Systems Engineer to join our team and contribute to the development of safe and effective medical technologies. The ideal candidate will have a strong understanding of hardware, software, and fluidics integration in regulated clinical environments.
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Main Responsibilities
* Lead systems engineering activities for electro-mechanical medical device platforms, ensuring compliance with regulatory requirements.
* Translate user needs and clinical requirements into system-level specifications, working closely with cross-functional teams.
* Define and manage requirements traceability, risk analysis, and design inputs/outputs, maintaining a high level of quality and safety.
* Support design verification and validation (V&V), including test planning and execution, to ensure the successful launch of new products.
* Collaborate with quality and regulatory teams to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and IEC 60601 standards.
* Participate in design reviews, FMEA, and hazard analysis to identify potential issues and implement corrective actions.
* Provide technical leadership and mentorship to junior engineers, promoting knowledge sharing and skill development.
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Ideal Candidate Profile
* Proven experience in medical device systems engineering, preferably with electro-mechanical or drug delivery systems.
* Strong understanding of embedded software, fluidics, and hardware integration, with excellent problem-solving skills.
* Familiarity with design controls, risk management, and regulatory compliance, with a keen eye for detail.
* Excellent communication and documentation skills, with the ability to work independently and collaboratively in a fast-paced environment.
* Aptitude for learning and adapting to new technologies and processes, with a passion for innovation and continuous improvement.