Sr Design Readiness Engineer - Integrated Resources, Inc
Newton, MA 02466
About the Job
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
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
Source : Integrated Resources, Inc