Senior Mechanical Engineer -Medical Device Canon Corp Cambridge MA
Senior Mechanical Engineer - Medical Device
Canon USA's Healthcare Optics Research Lab is collaborating with world-class hospitals in the Boston area to turn cutting-edge medical research into usable, meaningful products. The Sr. Mechanical Engineer (Engineer, Sr.) will lead design and implementation of a robotic catheter system from initial concept through commercialization, in collaboration with the world-class hospitals.
Responsibilities
- Provide mechanical specifications for the mechanical components in the robotic catheter system to reflect clinical requirements
- Directly responsible for design, analysis, drafting, fabrication, testing and documentation of key mechanical components and assemblies from prototype through commercial release
- Work with electrical and software engineers to define the specifications of the control component, and conduct system integration
- Work closely with design and usability engineers to ensure the form and function of the mechanical and control components reflect human factors requirements
- Ensure all components and assemblies meet all appropriate medical device standards
- Conduct and document feasibility studies, tolerance analysis, FEA and other appropriate tests with bench-top environment as well as pre-clinical models (ex. anatomical phantom and animal model)
- Produce production level assembly and part drawings for all components and sub-assemblies
- Contribute to risk analysis, including dFMEA and pFMEA, to assure product safety and reliability
- Lead and manage mechanical design verification activities for the system
- Create and manage the Bill of Materials (BOM) for components and sub-assemblies within the optical imaging device
- Work with operations engineers to evaluate and make recommendations for the selection of contract manufacturers for the medical robotic catheter system
- Provide documentation of inventions for patent applications
- Review alternative technology IP as it relates to the design process
- Interact effectively and appropriately with a cross-functional team in R&D, Clinical, Quality, Regulatory, Marketing, Operations and external stakeholders
Qualifications
- BS or higher degree in Mechanical Engineering or related discipline
- 5 years of experience in design of products or prototypes of medical device and/or mechatronics device
- Excellent modeling and drawing skills using Solidworks, including proficiency with assemblies that contain dozens of parts
- Excellent understanding Matlab/Simulink for motion control for mechatronics device
- Deep experience with design for manufacturability
- Proficient with rapid prototyping techniques