Job Information
Meridian Bioscience, Inc. R&D Engineer II in Cincinnati, Ohio
R&D Engineer II Job Locations US-OH-Cincinnati Company Meridian Bioscience, Inc. Department Research and Development
of Openings
1 About Meridian Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems. Job Summary The candidate will be responsible for supporting medical diagnostic instrument related (hardware, firmware, and software) development and testing activities and as well as associated engineering tasks. The candidate will work within R&D Engineering, participate in cross-functional project core teams, and interact with various departments within the organization. Additionally, the candidate will support other teams at our Meridian global sister R&D sites and businesses in line with business needs. The responsibility of R&D Engineer II position will also involve identifying challenges in R&D data backup processes, developing solutions, and presenting them to the core team. The R&D Engineer II will also work independently as a cross-functional team member for various IVD projects. Key Duties Major Duties & Responsibilities: Support other MBI R&D sites and business units Prepare technical documents with RA team for 510(k) submissions Lead instrument and software related validation and verification projects Design, develop, and improve R&D instrument related workflows and SOPs Manage instrument and software update control process for Curian, Curian Flex, and M10 platforms Lead the engineering part of one or multiple New Product Development projects Participate at the core team level and support tasks such as: DHF document review and management Technical troubleshooting Risk analysis Technical documents for regulatory submissions Change control Instrument and software release management Participate and contribute as a functional point of contact to new product design and development activities, including but not limited to: Gather user requirements Develop specifications Guide design of a GUI and user workflow Develop software and operating manuals Hardware/software issue troubleshooting, tracking, and management Prepare for and participate in engineering product or process design and reviews with internal R&D team members as well as global sister R&D organizations and other businesses. Act independently to design and author SOPs and determine necessary verification and validation test methods for automated software tools/processes, instrument hardware, software, etc. Provide technical updates as a knowledge resource to the R&D department and project teams for all ongoing engineering tasks. Participate in troubleshooting, CAPA, and quality audit activities. Act independently and sometimes lead in the continuous process improvement activities to reduce waste and boost organizational efficiency for the R&D department. Operate in accordance with the company's quality system. Other duties as assigned: Ability to go up and down several flights of stairs throughout the workday in a multi-location facility. Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.) and adhere to applicable bio-safety practices when on