The company has the ambition to offer diagnostic medical devices, with clinical lab performance, the ease-of-use of a pregnancy test, a consumer price tag, and for use at the point of need.
They implemented a Quality Management System to provide products that consistently meet customer and regulatory requirements as applicable for (in vitro diagnostic) medical devices. Besides, the company oriented its Quality Management System to obtain, treat, store and make available Human Biological Samples, for the purpose of product development, in accordance to the applicable regulatory requirements, in focus ethical, biosafety & data protection requirements.
The IVD Product Integrator will lead the development of a specific product, i.e. a test on the company's platform, through the various phases of In Vitro Diagnostics Medical Devices development: feasibility, design, optimisation, verification and validation, compliant to FDA and CE-IVD guidelines.
In this role, he/she will closely work together with several technical disciplines of the platform, as well as the interface with quality to make sure the product is compliant.
- Design and Development of the product in concordance with Design Control methodologies, applicable to medical device development in the context of a regulatory filing to FDA and CE, in concert with the quality and regulatory team.
- Manage the product development of the system components of a specific product from design phase to market entry.
- Maintain a system vision over the several subcomponents of a product: reader, consumable, kit and digital application.
- Manage the project taking into account the RACI matrix and follow up with tasks and deliverables.
- Responsible for D&D documentation accompanying the various stages and phases of development, in concordance with the copmany's D&D processes and its deliverables.
- Management of Product Requirements Document (PRD) Trace matrix; ensure all Product Requirements are translated and followed up in specifications, verification tests and validation tests.
- Interface system subcomponents (reader, cartridge) and integrate to product level including product peripherals, such as app, pipette, sample collection device.
- Plan and align verification and validation activities on system level adhering to medical device industry standards.
- Manage Failure Mode & Effect Analysis (FMEA) (use FMEA, design FMEA, process FMEA) – plan, review and translate to Requirements & Specifications.
- Establish and maintain Design History File.
- Lead the transfer to manufacturing of a specific product and align with critical processes existing in production.
- Establish manufacturing QC methods during design and implement during production phase.
- Follow internal quality management system processes.