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We are looking for a Clinical Affairs Manager to implement and oversee all activities related to clinical research and clinical studies in the company.
DiA Imaging Analysis provides AI-powered solutions to make ultrasound image analysis smarter and more accessible.
Its AI-based solutions help ultrasound users acquire the right image and analyze it automatically, allowing them to identify clinical abnormalities that are often difficult to find visually and enabling them to make better decisions based on accurate and objective data.
Your role:
Designing and managing the execution of clinical studies that demonstrate medical product safety and efficacy.
Ensuring that trials are conducted in full compliance to GCP.
Full responsibility on sites initiation, site personnel training and monitoring.
Working closely with the principal investigators and study coordinators.
Working with regulatory, development and marketing teams to create scientific publications, clinical marketing material and clinical background required for regulatory submissions.

We are hiring a Senior Program Manager to join our PM team. A cancer patient wants to know that their diagnosis and treatment are determined with the greatest precision and preferably using the most advanced technology. At Nucleai, we bring cancer patients cutting-edge AI-based technology by improving biopsy interpretation with machine learning and creating novel precision medicine technology. Come join our team of experienced AI engineers and world-renowned clinicians, and help us make a difference. At Nucleai, we believe that talents are our most valued asset, and as such, hiring the right people is one of our most strategic missions.
Responsibilities:
* Lead complex projects that encompass both internal and external stakeholders.
* Communicate project goals and customer needs to R&D teams
* Present Nucleai’s solutions and mode of work to existing and new customers.
* Lead the projects end-to end while providing a great customer experience.
* Oversee the day-to-day work on projects while managing the work of the project task force.
* Collaborate across range of internal and external groups: Product, AI, Research, and the company leadership.

We are looking for a Director Supplier and Production Quality.
This position will focus on improving product quality through data analysis,
investigation, issue resolution and collaboration with both internal and external parties. This person will be responsible for driving the non-conforming material process and root cause investigation through coordination with engineering & R&D organizations.
You will be responsible for making final decisions on production and supplier quality along with ensuring NPI, engineering, supply chain and fulfilment as well as production effective achievement of quality and compliance objectives.
In the role of Production & Suppliers Quality director you will oversee iTero production in various global facilities; youll also be managing suppliers and contract manufactures for iTero from around the globe.
In this role, you will:
Drive product quality improvements in production and with suppliers
Manage a team of quality engineers & the QC Dept.
Manage the NCM and MRB processes.
Lead analysis of defects data (NCM, RMA and DOA)
CAPA/ SCAR creation / resolution and maintain records as specified by the quality system
Lead QC team and drive incoming inspection improvements, such as direct- to- stock, reduction of MRB and non-conforming material inventory.
Interface with other functions on supplier related defects
Conduct root cause analysis on product quality issues, identify trends, and communicate with Engineering/ R&D on a regular basis.
Be responsible to oversee that Operations are working according to released and validated work instructions to ensure that a device conforms to its specifications.
Be responsible for process- related Validations across the company process, support SW, mold, jigs
Ensure the creation of accurate, complete and timely records and DHRs
Set the yearly suppliers audits plan and execute with the team
Be responsible for evaluating current suppliers, approving new suppliers and disqualifying suppliers
Support the introduction of iTero production lines in other facilities around the globe and with external contract manufacturers.
Work with our Global on the integration and harmonization of Purchasing controls and Production and process controls related SOPs, suppliers audits and supporting IT systems.
Support PFMEA creation and update and any other process and suppliers' risk- related activities
Additional responsibilities:
Be aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/ position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support external bodies audits on- site
Perform internal audits.

We are looking for a System Engineer Expert to drive the system vision, architecture and design requirements of multi-disciplinary state of the art 3D imaging medical systems.
The System Engineer is required to understand the user needs, product constraints and be responsible for defining the architecture and system requirements for the medical device. The work process is focused on balancing implementation complexity, clinical constraints , risks, manufacturability, serviceability and quality to conclude the optimum design alternatives. He is required to work closely with the product managers, customers, QA/RA and design teams from needs translation to requirements and architecture to allow development plans up to design transfer to production.
In this role, you will:
Master multi-disciplinary system including Electronics, Mechanics, Algorithms, Software (embedded and application),Physics and optics, lead and develop the architecture and requirements of such systems.
Analyze design alternatives for all the system features , such as design complexity, timelines and risks, technical and clinical performance, manufacturability, cost, etc., and lead the technical decision making while collaborating with cross-functional peers within and outside R&D.
Work with program managers to create and manage project schedules.
Design and lead lab experiments and integrations, analyze and solve problems of real complex systems in lab, in production, or in the field.