Position Title: Sr Design Readiness Engineer (Contract) Company Background: Client Healthineers Company, Endovascular Robotics (EVR) division, is a global technology leader in robotic-assisted vascular interventions. The company's CorPath® system is the first FDA-cleared medical device to bring robotic-assisted precision to neurovascular, percutaneous coronary and peripheral interventions. EVR is advancing the field of interventional medicine with robotics through improvements to procedural control, precision, and workflow. Position Summary: The Senior Design Readiness Engineer will be a part of the R&D organization and an important contributor to the realization of the next generation robotic platform that will change the future of healthcare. You will be a highly visible technical resource working on the transition of complex electro-mechanical assemblies from prototype to verification builds and testing, in close collaboration with manufacturing engineering. This role is suited for an R&D engineer with experience in developing, building, and testing complex electro-mechanical medical devices, design transfer, and process validation with broad knowledge of mechanical, mechatronics, firmware, software, and systems engineering, including design verification testing, and transfer to manufacturing within a regulated medical device development environment. Key Responsibilities: • Being a key team member working on design readiness of the robotic system • Support development of assembly and test processes • Support identification of, specification creation for, development and characterization of in-line test and build fixtures • Support development and maintenance of the BOM and DMR • Specify firmware and software development requirements for test and build fixtures • Author relevant documents such as build process, assembly instructions, inspection procedures, test protocols, test reports, analyses, and system documentation • Support a variety of multi-disciplinary technical and process improvement projects of different sizes and Products • Help with the vendor communications and procurement issues • Support creation of DHF and release of documentation to quality system • Manage and communicate assigned projects in collaboration with cross-functional teams Qualifications: • 8+ years electromechanical R&D engineering experience, at least 5 years in medical device required • Bachelor's degree in Mechanical/ Robotics/ Mechatronics/Advanced Manufacturing Engineering or a close field is required • Deep understanding of DFM ( Design for Manufacturing ), DFA ( Design for Assembly ), and DFT ( Design for testing ) required. • Experience in managing engineering projects required • Expertise with firmware and software within electromechanical systems is highly desired • Knowledge of PCBAs (understanding the design, testing, and documentation) is highly desired • Must have previous experience in design transfer/new product introduction • Must have in-depth knowledge of design verification of complex medical devices • Must have deep knowledge and working experience of medical device design control • In-depth knowledge and experience in transferring design to manufacturing is required • Experience in off-the shelf component selection for regulated industries highly desired • Experience with statistical tools and software such as Minitab and MATLAB desired • Able to execute assigned projects and duties with minimal supervision • Outstanding documentation and communication skills required • Proficiency in using MS Office and Solid-works required
Job Title
Sr Design Readiness Engineer