As part of our product team you will:

• Serve as a first Project Manager in an excellence driven, fast growing startup.

• Proactively coordinate across various stakeholders such as Engineering, Product , 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 2 years in managing software development projects or related experience

• At least 2 years’ experience working in a medical device software / highly regulated  environment

• Degree in Software Engineering or experience in software development a plus

The ideal candidate displays the ideal skills and competencies:

Software Development

• Experience developing software or managing development of software in a regulated environment

• Experience using common software development tools for development and testing (JIRA, GIT, Jenkins, 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.

• Able to translate user needs into testable specifications

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 authorization in the USA, and the impact of software changes as they relate to marketing submissions.

General Management

• Flexible work hours that can accommodate team members in Tel-Aviv and the USA.

• Able to identify project deliverables, assign and manage tasks and responsibilities to achieve deliverables, and identify rate-limiting activities in the software development and software release cycles

• Able to document and coordinate project documents in an efficient and in a way that is consistent with current regulations.