Analyst/Test Engineer

• Nov 2019 - Present

Main Contribution: - Ensuring that our software products implement efficient, accurate and robust patient management and clinical diagnostic and therapy solutions that will benefit clinicians, their patients and the health system as a whole. - Define requirements for our software products and tests of platforms and AI solutions to ensure they benefit as many as possible without any risk of harm. - Design automated testing and deployment processes, to bring agility into medical device development. Main Responsibilities: - Design and develop the requirements for Optellum products, in close partnership with the Engineering team. - Develop and implement testing strategy for the software infrastructure and code that will be the core of Optellum products, using maximal level of automation testing. - Contribute to the choices of technologies and platform for the Product and the future technical choices for the new product development directions. Choices will be discussed with the VP of R&D, CSTO and the Lead Developer. - Test the Product to the best quality standards. - Elaborate the Technical File for regulatory submission in the countries where Optellum operates, with support from the QA/RA manager. Show less

Quality Officer – Product Development

• May 2019 - Nov 2019

Provide an independent quality review for the firm’s development projects to ensure that relevant regulatory requirements are met, applicable standards are conformed to and that procedures are followed. This will be performed by: • Attending project development meetings (in particular milestone / gateway meetings), design reviews etc. • Reviewing and approving project plans and schedules to ensure that required work and documents are scheduled to be developed. • Reviewing and approving design specifications, architecture documents, software FMEAs, test plans and reports to ensure development activities are being performed in conformance to relevant SOPs, standards and plans. • Performing audits internally and with external third-parties (suppliers, consultants, technology providers etc.) to ensure and document requirements are met. • Performing (or collaborating on) computer systems validation for the firm’s development tools. • Raise non-conformance reports (NCRs) and assist in the execution of corrective actions (CAPA) as required. • Assist colleagues with the facilitation of design change control and its implementation into production. • Maintain and improve QMS procedures as required. • Identify, monitor and report of patterns and trends for QMS related issues. • Ensure that the Quality Plan and Quality Goals for the year are met. • Perform other duties as assigned and to escalate risks and issues to management. Show less

Software Analyst

• Apr 2017 - May 2019

Main duties and responsibilities:- Product Planning • Working with Product Management to define the content of products and versions via the production of business requirements in the form of product vision documents. • Maintaining a list of prioritized feature requests for subsequent assignment to product versions. • Gathering feature/requirement requests from any source available, including but not limited to costumers.- Product Specification • Specifying customer requirements using appropriate requirement notation in product/user requirements specifications. • Prioritization of requirements. • Clarifying requirements concepts with customers/end users during the specification process to ensure that the understanding of their need is correct at the earliest opportunity within the development process. • Coordinating with the development team to specify software requirements and product design that meet the customer/product requirements. • Managing Requirements Change Requests. • Reviewing any architectural/UI design /low level requirements specifications to ensure they adequately meet the intent of the higher level requirements specifications.- Product Verification/Validation • Creating and executing validation and verification tests and creating reports as required. • Reviewing test specifications/plans/reports created by development, as required. • Prioritization of defects within products relating to customer/end user needs. • Ensuring that products have been adequately tested prior to release to customers/end users. • Contributing to/reviewing user documentation. • Working with customers/end users to allow them to use delivered products effectively.ively. Show less

Project Engineer

• Oct 2014 - Apr 2017

Performing R&D activities on development projects as part of a project team, to include:- User, product software and software analysis- Software design and development- Testing and test designWorking with OEM partners and costumers to support Mirada products and activitiesWorking with other groups in Mirada to define and deliver products

Test Engineer

• Feb 2014 - Oct 2014

Internship

• Oct 2011 - May 2012

Scientific research, image analysis and processing, development of algorithms on the basis of information provided by doctors. Scientific research, image analysis and processing, development of algorithms on the basis of information provided by doctors.