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Submitted by pnehru_from_pa… on Wed, 02/26/2025 - 18:25
Description

Articares is a leader in innovative medical technologies, developing human-like decision-making robotics and artificially intelligent solutions that facilitate personalised rehabilitation after injuries such as stroke, dementia, and accidents—common occurrences in an ageing population.

These solutions result from close collaboration between experts in the medical and engineering fields, backed by clinical studies, and delivered by a dedicated team committed to making every step of the rehabilitation journey smoother and more manageable.

Today, Articares is one of the fastest-growing companies in this field, with solutions deployed in major healthcare institutions across Singapore, APAC, and the EU. By combining innovations with out-of-the-box business offerings, Articares provides comprehensive support throughout the hospital-to-home journey of patients.

Project role: Medical Robotics Engineer for Quality Management Systems and Regulatory Compliance of AI-based intelligent rehabilitation robotics

Key Responsibilities:

1. Shape effective regulatory strategies for future product launches, ensuring faster and compliant market entry.
2. Continuously monitor evolving standards in AI, robotics, and medical devices to propose innovative development approaches that accelerate time-to-market.
3. Work closely with hardware, software, and AI teams to identify and resolve technical and non-technical challenges, improving both software and robotics development cycles and quality management systems.
4. Initiate and engage in risk management (FMEA) activities specifically involving robotics, AI, and cloud systems, collaborating across teams to mitigate risks and ensure product safety.
5. Develop and maintain AI and robotics technical files, ensuring full compliance with ISO 13485 and other key regulatory standards essential for Deep Tech robotics companies.
6. Build and improve inter-departmental operating procedures and communication strategies to enhance operational efficiency involving robotics, AI, and cloud technology.
7. Manage all activities related to post-market surveillance of deployed robotics and software, ensuring timely closure of customer complaints and CAPA.
8. Assist with other activities as tasked by the management to ensure the smooth operation of the quality management system.

Requirements:

1. Bachelor’s degree in a relevant field, such as engineering, law, medicine, pharmacy, or other scientific disciplines, with a preference for biomedical engineering.
2. Minimum of 1 year of professional experience in regulatory affairs or quality management systems related to medical devices.
3. Strong organisation and communication skills, with proficiency in MS Office tools.
4. Engineering experience in biomedical devices is advantageous.

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Project Name

Medical Robotics Engineer for Quality Management Systems and Regulatory Compliance of AI-based intelligent rehabilitation robotics

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