Apn Software Services - Newton, MA

posted about 1 month ago

Full-time - Mid Level
Newton, MA
Professional, Scientific, and Technical Services

About the position

The Senior Design Readiness Engineer at Siemens Healthineers will play a crucial role in the R&D organization, contributing to the development of the next generation robotic platform for healthcare. This position involves transitioning complex electro-mechanical assemblies from prototype to verification builds and testing, collaborating closely with manufacturing engineering. The ideal candidate will have extensive experience in developing, building, and testing medical devices within a regulated environment, focusing on design transfer and process validation.

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

Requirements

  • 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

Nice-to-haves

  • Expertise with firmware and software within electromechanical systems
  • Knowledge of PCBAs (understanding the design, testing, and documentation)
  • Experience in off-the-shelf component selection for regulated industries
  • Experience with statistical tools and software such as Minitab and MATLAB
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