Position Title: Sr Design Readiness Engineer (Contract)
Company Background:
*** 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 scopes
" 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 Solidworks required