Sr Design Readiness Engineer - Newton, MA, 02466

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.

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