EDDA Technology does work that matters with an outstanding team who believes in making a difference for our medical facilities, clinicians and their patients.
Regulatory Affairs Manager
Job Description:
A Regulatory Affairs Manager position is available at EDDA Technology, Princeton, NJ.
Responsibilities include:
- Responsible for maintaining and updating interval processes and activities to meet Quality/Regulatory requirement;
- Working closely with product team on maintaining and improving product and process quality, as well as on submission activities for US 510(k);
- Participate in FDA inspections;
- Responsible for Regulatory related internal training;
Required qualifications:
- BS/BA or advanced degree in related discipline.
- Must have 5+ years of experience in Regulatory Affairs, preferably with a global manufacturer of medical devices including software.
- Successful experience in FDA 510(k) and inspection.
- Must have strong knowledge of compliance with FDA QSR and ISO 13485.
- Working knowledge of EU MDR and regulatory requirement in Asia a plus.
- Must have excellent written and verbal communication skills.
Company Introduction:
Excellent opportunity with a dynamic, growing medical technology solution company.
EDDA Technology is an innovative leader in the rapidly growing field of intelligent robotic solutions for precision surgery. Pioneering a “fully quantitative, interactive” approach to intelligent imaging analytics and robotic integration, the company has built a proprietary technology platform to facilitate pre-surgical planning and simulation, intra-operative navigation, post-operative evaluation. With its end-to-end enabling platform, EDDA’s goal is to form a comprehensive ecosystem of clinical practice, connection and education to support physicians and patient management in all tiers of hospitals. IQQA® is a registered trademark of EDDA Technology. (www.edda-tech.com)
Compensation/ Benefits
EDDA offers a competitive salary, performance based incentive stock options, and excellent benefits including medical and dental insurance, vision care, 401k plan, section 125 health and dependent care (flexible spending) accounts, and paid vacations. The company sponsors the H1-B application.
Send applications to: hiring@edda-tech.com
AI Research Scientist -- Medical Imaging Analysis
Job Description:
There are multiple AI Research Scientist-Medical Imaging Analysis positions available at EDDA
Technology, Princeton, NJ. Responsibilities include:
- Design, implementation, and verification of deep learning algorithms for 3D and 2D segmentation and registration problems on medical images;
- Define, develop and validate clinical solutions;
- Lead and conduct extensive AI research to develop new methodologies and technologies related to Medical Imaging;
- Design experiments and prototypes to test the viability and efficiency of new AI models;
- Fast prototyping of image and video analysis product modules;
- Stay updated with the latest AI research and advancements;
- Collaborate closely with clinical customers to solve real-world problems;
- Conforming to the Company’s standard/procedure of product development;
- Efficiently communicating with project managers and team members on the execution;
- Other job responsibilities as assigned by the management.
Candidates shall meet part of the below qualifications:
- Strong background in Artificial Intelligence, Machine Learning, Deep Learning and/or Medical Image Analysis;
- Coding skills and ability to quickly prototype Deep Learning models is a must;
- Experience and skills in working with deep reinforcement learning (deep RL) is a must;
- Strong algorithm development skills with in-depth knowledge on medical image analysis/segmentation, image registration, computer vision, deep learning, real-time processing, and GPU programming;
- 3+ years of experience in the related fields preferred, with excellent software engineering skills in using C/C++; Other software skills preferred include Python, Pytorch, Tensor Flow, and Keras; Experience and skills in working with large language models (LLMs), large vision models (LVMs), and natural language processing (NLP);
- Strong problem-solving skills with quick implementation and verification; Strong team player and highly self-motivated individual with desire and ability to learn quickly;
- Written and verbal communication skills in English are required;
- PhD in AI/ML/CE/EE/CS/Bio-Engineering.
Desired qualifications:
- Knowledge in human anatomy and interpretation of medical images a plus;
- Hands-on experience and knowledge in DICOM a plus;
- Experience in processing ultrasound images a plus.
Company Introduction:
Excellent opportunity with a dynamic, growing medical technology solution company.
EDDA Technology is an innovative leader in the rapidly growing field of intelligent robotic solutions for precision surgery. Pioneering a “fully quantitative, interactive” approach to intelligent imaging analytics and robotic integration, the company has built a proprietary technology platform to facilitate pre-surgical planning and simulation, intra-operative navigation, post-operative evaluation. With its end-to-end enabling platform, EDDA’s goal is to form a comprehensive ecosystem of clinical practice, connection, and education to support physicians and patient management in all tiers of hospitals. IQQA® is a registered trademark of EDDA Technology. (www.eddatech.com)
Compensation/ Benefits
EDDA offers a competitive salary, performance-based incentive stock options, and excellent benefits including medical and dental insurance, vision care, 401k plan, section 125 health and dependent care (flexible spending) accounts, and paid vacations. The company sponsors the H1-B application.
Send applications to: hiring@edda-tech.com