3 remote jobs

Day in the life In this role you'll get ... Work closely with the scrum team to drive, implement, and maintain tests for a Medical Device in an agile environment. Understand and provide input around test process, tools and methods. Recommend and implement improvements to test strategy. Interpret requirements for testability and ensure coverage in test case design. Assess impact of design changes to determine optimal level of testing. Understand and apply principles of SDLC and methods such as Lean/Agile/XP, Software and Product Security, Scalability, Documentation Practices, refactoring and Testing Techniques. Work with the team to define, build and maintain the test infrastructure and environments. Integrate testing with continuous-integration process. Work with fellow team members to diagnose bugs and formulate solutions. Use test automation techniques (data driven, pairwise, mocking, test hooks) that fit the problem space. Understand designing and...

We're looking for... Someone who can use Agile working methods to design, implement and execute design control processes for Software as a Medical Device and mobile app/cloud components of connected device systems Someone with a design and engineering mentality. This includes understanding how to design complex systems and sub-systems, and applying design controls when there is a lot of change Someone who will be a key technology and process leader at Orthogonal. You will be intimately involved in almost every aspect of a solution lifecycle, from project inception, engineering design and implementation to maintenance and continuous improvement Key Tasks for Systems Engineer Design quality processes optimized for frequent releases Active participation in design, development and deployment activities by working closely with Architects, Engineers, Product Managers, Scrum Masters and Project Managers Curate traits of quality in the culture of Software as a Medical...

Job Description: The primary focus of the Regulatory Affairs Specialist is to work closely with Quality and Engineering on the development, management and maintenance of regulatory-related registrations and processes for NICO’s products, and to participate and/or support in the development of new products. Responsibilities are, but not limited to the following: Preparing and/or managing the outsourcing of regulatory documentation for NICO’s products, including technical documentation, device licenses, 510k submissions, etc. Management of international registrations for NICO’s products (Canada, Australia, Europe, UK, Japan, etc.) Assessment of Regulatory requirements within new potential markets Writing and/or outsourcing the writing of Clinical Evaluation Reports in accordance with MEDDEV 2.7/1 rev 4, and Post-Market Clinical Follow-Up Report in accordance with MEDDEV 2.12/2 rev 2. Developing, supporting and executing regulatory plans and strategies,...