Mechanical Developer 3

Position Title: Sr Design Readiness Engineer (Contract)
Company Background:
Client Endovascular Robotics (EVR) division is a global technology leader in roboticassisted vascular interventions. The companys CorPath system is the first FDAcleared medical device to bring roboticassisted 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 electromechanical 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 electromechanical 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 inline 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 multidisciplinary 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 crossfunctional teams
Qualifications:
8 years electromechanical R&D engineering experience at least 5 years in medical device required
Bachelors 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 indepth knowledge of design verification of complex medical devices
Must have deep knowledge and working experience of medical device design control
Indepth knowledge and experience in transferring design to manufacturing is required
Experience in offthe 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