Healthcare Needs AI, AI Needs Talents

 

Do you want to work towards a meaningful impact?

 

If so, join us!

Responsibilities

• Contribute to developing and implementing global regulatory strategy and roadmaps through a deep understanding of the competitive market landscape, initiatives, and product
• Responsible for the planning, coordination, preparation, and completion of document packages for regulatory submissions to the US, EU, Canada, Japan, etc. (e.g. pre-submissions, 510k) and building the technical files as well as the design dossiers and authoring summaries
• Participate in meetings with the FDA and other 3rd party external regulatory agencies
• Stay informed regarding new guidelines and regulations for successful implementation in the QMS
• Review and improve the QMS based on FDA QSR and the harmonized standards ISO 13485, ISO 62304, ISO 62366 and ISO 14971
• Serve as the consultant for engineering, manufacturing, and clinical teams throughout the design control process; offering regulatory expertise during design input & output creation, verification, validation, design transfer, pre-clinical, and clinical testing, including review of design documentation to meet regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provide guidance to the team on risk assessment and required corrective actions to meet regulatory requirements
• Identify and help resolve product development issues which regulate to regulatory submission activities
• Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways 

Requirements

Minimum bachelor’s degree in an appropriate scientific or other related fields, RAC certification preferred

• At least 2 years experience, of which at least 1 year in the regulatory environment of the Software Medical Device industry with excellent knowledge of the regulations for design of Software as a Medical Device (SaMD)
• Experience with successful preparations and submissions packages for registration purposes
• Experience in design control processes
• Ability to work autonomously to solve problems and demonstrates excellent analytical skills
• Knowledge and practical understanding of ICH Guidelines regarding GxP, preferably also MDR and IVDR
• Skilled in cross-functional project management in a regulated industry, especially in discussing controversial topics such as device risk, device classification, including MDDS, and human factors studies
• Knowledge of effective and compliant engineering and communication practices to enable technical teams
• Ability to work under tight timelines
• Being persistent and having strong collaborative and team spirit skills.

MAIN RESPONSIBILITIES

• Coach and mentor our Algorithm team.
• Plan, design, and carry through short-term applicative challenges as well as long-term research projects.
• Leading the company’s technical aspects.
• Investigate, identify, and implement novel research ideas 
• Provide input for future planning based on the area of expertise.

REQUIRED

• MSc  (with thesis) in Computer Science or equivalent is a MUST. A Ph.D. degree is an advantage.
• More than 5 years of experience required as an Applied Machine-Learning / Algorithms Engineer / Computer Vision Engineer.
• MUST Experience in leading long-term data research projects from vision to implementation.
• Deep Learning for Computer Vision in-depth knowledge
• Familiarity with toolkits for deep learning such as TensorFlow/PyTorch
• A team player with good communication skills, both written and verbal
• Gets things done attitude

Requirements

• MSC. in computer science, preferably in the field of Machine Learning / Computer Vision algorithms.
• 3+ years of Hands-On development of complex machine learning models using modern
  frameworks and tools (ideally python based)
• 1+ year of Hands-On experience with Deep learning using common open source
  frameworks and tools (Keras, TensorFlow, Theano, Caffe etc.)
• Strong communication and collaboration skills
• Team player, positive and driven, fast learner

Skills

• PHD in machine learning – very strong advantage
• Experience in computer vision – a very strong advantage
• Publications/public speaking experience in the field of Machine learning – strong advantage
• Experience in engineering, especially working with CI, Docker, Hadoop, and distributed systems – strong advantage

Requirements

• 3+ years as DevOps in a software company.
• Experience with CI\CD practices and relevant tools like Gitlab, Jenkins, etc.- A Must.
• 1+ years with Docker in production – Is a Must
• Experience with provisioning, configuration management and
  automation tools such as Terraform, Ansible, Salt, Chef, Puppet.
• Hands-on experience with Monitoring & Logging stacks- ELK, TICK stack, Prometheus.
• Experience with coding in Python/Node/C#/Java or any other programming language
• Strong Linux skills
• Experience with provisioning and configuration management tools such as Terraform, Ansible, Salt, Chef, Puppet.
• Experience building/supporting a large distributed production environment
• Deliver first-class work on tight schedules that supports a self-service approach
• Team-player with good communication skills

Skills

• Anything from our technology list is a big plus:
  Docker, Rancher, Kubernetes, GitLab, Ansible, Prometheus, ElasticSearch, Kibana, AWS, GCP,
  Jenkins, CephFS, MaaS, GPU, Node.js, Mongo DB, Postgres, TensorFlow, Python and more…