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As a regulatory affairs expert, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities

In this role, you will
Be a focal point for the RA team members to solve professional issues
Train the junior team members in their onboarding process and on specific skills and knowledge development.
Develop of regulatory strategies for product development and approval, as well as product lifecycle maintenance. Develop global strategy for product launch.
Prepare document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Support license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post approval changes
Coordinate project submission timelines in multiple regions
Escalate issues that affect registration, regulatory compliance and continued lifecycle management of the product

Do you want to join an international team in Israel within an innovative fast-paced medical device company?
We develop state-of-the-art products, which focus on revolutionizing the digital dental practice.
Key Responsibilities


In this role, you will
Develop automated HW ATE - SRS, scripts and logic.
Integrate with other applications API.
Create and run ATE in production line with DB connection.
Work in a scrum team applying agile methodology.
Automate test cases from requirements and manual tests as part of scrum team developments.
Collaborate with other applications teams.
Work with bugs stored in bug tracking system: identifying bugs, documenting, fixing, communication with software developers and internal customers.

We are looking for a Senior Manager to lead our Algorithm Platform team, who will be responsible for scaling our AI data infrastructure and algorithmic infrastructure across both cloud and on-device (iTero scanners) environments. This role requires strong technical background, strategic leadership, and a deep understanding of AI/ML workflows, data pipelines, high performance algorithmic software and scalable infrastructure.


In this role, you will
Manage and mentor a high-performing data and algo infrastructure team, fostering a culture of innovation, agility, and technical excellence
Drive the development and optimization of AI data infrastructure, algorithmic infrastructure components, and model deployment pipelines on cloud and edge devices.
Work closely with the entire Algo organization teams and R&D functions to align platform capabilities with business needs.
Define and execute the roadmap for the development of AI and algorithmic infrastructure both on-prem and in the cloud.
Build the Algo Organization development methodologies and tooling, including CI/CD / MLOps best practices, reliability, and cost optimization.

This position is ideal for Senior support manager to join the Global Customer Support Excellence group as a Tier 3 Sr. manager.

In this role, you will be responsible to lead and manage a team of level 3 technical and product experts, who Serve as iTero Technical & Business focal point for regional support issues, and act as the primary link between the Field and the Organization.

As a Tier 3 Support Sr. Manager, you will be managing escalations and severities from the field, as well as leading highly complex customer support projects that require cooperation of many units in the organization, such as improving trouble shooting protocols and implementing support tools.

Key Responsibilities

Manage and mentor a team of Tier 3 experts, workload, emergencies and ongoing activities.
Build training plans for the team, make sure they are familiar with new development/ECOs.
Learn our customers and applications. Travel and meet Dr and labs in all regions.
Accountable End2End for problems solving till customer receives feedback
Work with the professional services team to support advanced activities and service improvements
Work with the knowledge and training team to help create and spread the global knowledge
Accept advanced cases escalated by support Tiers 1 & 2, Professional Services, and Partners.
Perform detailed problem analysis and root cause determination.
Escalate complicated unsolved issues including detailed logs, casework notes, diagnostics, and reproduce steps.
Provide assistance and knowledge to members of lower tiers.
Support NPI activities UAT, LMR and product launches.
Provide Feedback from the Install Base to R&D (functionality/HW)
Suggest improvements to the product based on field experience

We are looking for a Validation & Verification Senior Manager to join our team. As part of the role, you will work closely with R&D to specify, execute, and report the required tests, as well as with QA / RA to ensure that the medical QMS complies. In this role, you will play a key role in ensuring the quality and reliability of our products through rigorous testing and validation. A strong technical background, excellent problem-solving skills, and the ability to work collaboratively with various teams are required for this role.
In this role, you will

Develop planning control of verification and validation activities, ensuring compliance with regulatory standards and company quality objectives
Hire and direct staff to meet scheduled commitments.
Evaluating and understanding our current state of testing and driving change to increase test automation and improve our overall testing practices.
Developing test strategies for test automation and manual verification and validation.
Develop the test development processes including designs, reviews, implementations, and test execution.
Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
Work closely with other teams to build and maintain testing infrastructure and tooling.
Work collaboratively with others to drive best practices and reduce the cost of V&V effort.
Periodically review how the test strategy aligns with the latest available technologies and industry trends

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities
In this role, you will
Actively contribute in the development of regulatory strategies for product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities with different partners and their global strategy for product launch.
Perform coordination and preparation of document packages for US FDA regulatory submissions, EU MDD/MDR Technical Files, and international packages.
Coordinate and implement MDR requirements related efforts in the organization
Assess product changes and their global regulatory impact.
Lead or compile all materials required in submissions, license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes
Coordinate project submission timelines in multiple regions

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.
Key Responsibilities
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.

We are seeking a highly skilled Cloud Services Developer to design, develop, and maintain robust cloud solutions enabling the execution and orchestration of complex algorithmic workflows. In this role, you will leverage your expertise in C# and cloud technologies to build scalable microservices and integrate cutting-edge tools within an AWS environment.
You will be part of designing systems that facilitate efficient algorithm deployment, execution, and seamless orchestration, ensuring high performance and reliability.
In this role, you will:

Collaborate with team members, fostering a supportive and high-performing environment.
Contribute to all phases of the software development lifecycle, from planning to deployment and maintenance.
Mentor and learn from peers while promoting high standards for documentation, code quality, and feature development.
Work closely with algorithm developers to design and orchestrate cloud services that emphasize performance, scalability, and seamless execution of algorithmic workflows.
Take ownership of production systems by monitoring their health, suggesting improvements, and driving greater stability and robustness to enhance the user experience.
Collaborate closely with performance testers, DevOps, and IT operations teams to optimize system performance and reliability.

We are looking for a Sr. Data/Algorithm Infrastructure Engineer to join our growing Data/Algo infra team. This is a key position in the design and development of ML / AI / algorithmic infrastructure to support the development of our next generation iTero scanners.
Key Responsibilities

Own significant parts in the design and development of our data / MLops infrastructure to support the development of ML/AI models and Algorithmic features.
Take part in the design, development and optimization of algorithmic infrastructure components of ITero scanner.
Work with large clinical datasets to support the development of real-life ML/AI solutions which would make real impact on the wellbeing of patients.
Work with Algorithm and ML engineers to identify future challenges and possible solutions.
Own the quality of your code over time.
Consistently demonstrate innovative thinking, strong partnership and high work ethics.

The Technical PM will take part in leading activities related to the Disposable Sleeve to increase production yield reduce MRB and initiate cost reduction activities, lead NPI activities to achieve robust manufacturing of Aligns products.
You will work closely with other disciplines in the organization to coordinate various activities such as purchasing, R&D, Quality, Planning, Production both in Israel and abroad.
Key Responsibilities
In this role, you will
Manage Projects of different scales, specifically Production automation projects
Establishing and maintaining projects Gantt, tracking projects progress, recognizing risks and applying mitigations
Leading Engineering Changes Orders as the prime interface to introduce necessary engineering/R&D changes while understanding the implications in Logistic, Testing and Production
Compose DVP /IOQ / PQP protocols for validation of changes at production line qualification