About Viz.ai

Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care across 1,500+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz.ai OneTM is an intelligent care coordination solution that identifies more patients with a suspected disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, Viz.ai One delivers significant value to patients, providers, and pharmaceutical and medical device companies.

We are growing and are looking for a Release Manager to join our mission in developing life saving software!

Job Description

As part of our program management team you will:

• Serve as a Release Manager in an excellence driven, fast growing startup.
• Proactively coordinate across various stakeholders such as Engineering, Product ,QA, Regulatory Affairs, and Research to ensure delivery, testing and documentation of software and algorithms.
• Organize and coordinate the implementation of changes according to the company’s Software Development Lifecycle (SDLC) procedure.
• Update records (Device Master Records, UDI reports, etc.) and reports associated with new software releases and field actions from currently deployed software.
• Conduct Risk Management meetings, evaluate risk, writing or updating existing technical documentation and review technical documentation for consistency.

You will love this job if:

• You enjoy building relationships and working across a number of disciplines with several individuals with unique skill sets to deliver a finished product.
• You are very detail oriented and have a hands-on approach to managing various documents and activities in day-to-day operations.
• Enjoy anticipating and adjusting for challenges and working in a fast-paced development environment.

Requirements:

Minimum 5 years in managing release / program management from SaaS software development companies Strong background in managing complex software releases and deployments. Very strong advantage for experience from medical device company, familiarity with V&V / QA / release management processes Experience with regulatory compliance requirements specific to medical devices (e.g., FDA, ISO).- a plus
Strong technical background in software development - a plusDegree in Software Engineering or other technical field related - a plus

The ideal candidate displays the ideal skills and competencies:

Software Development

Experience using common software development tools for development and testing (GIT, JIRA, etc.)Working knowledge and application of IEC 62304 in the Software Development Lifecycle and documentation expectations for demonstrating compliance with this standard. (IEC 82304 experience a plus)Experience writing technical documentation related to risk, software requirements, software design, and testing protocols (verification and validation).

Product Development

Understanding of product-driven development needs and the downstream effects to technical documentation and testing. Familiar with general UI expectations and conventions.

Regulatory Affairs

Understanding of regulatory requirements for design controls, software development, and evidence to support design, verification, validation, and release activities. Experience creating, managing, reporting and maintaining unique device identifiers (UDIs) for software devices in the USA (international experience a plus).Demonstrated experience evaluating field reports, complaints, and post-market feedback to identify reportable events and triage of software maintenance and improvement. Understanding of regulatory terminology (e.g., intended use, indications for use), submission types for marketing authorisation in the USA, and the impact of software changes as they relate to marketing submissions.

General Management

Self motivated and quick learner. Flexible work hours that can accommodate team members in Tel-Aviv and the USA.Able to work on multiple projects simultaneously in a continuous changed environment.

Why should you join us?

If you are looking to make an impact -join our mission. If you want to be a part of an amazing team -our people are the heart of everything we do.If You are a self-starter and naturally motivated. You have a passion for the healthcare industry

Location:

We are located in San Francisco, Tel Aviv, This position is based in Tel Aviv.

Our office in Tel-Aviv is located in Menachem Begin 150, within walking distance of Arlozorov and Ha'Shalom train stations.

We are working hybrid and our in-office recommendation policy is two days a week.

Your dog is welcome to join you! :)

For any additional information or if you have questions, please contact Liron@Viz.ai.

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