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    Lead Mechanical Engineer - Orlando, United States - LTTS

    LTTS
    LTTS Orlando, United States

    4 weeks ago

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    Description

    Responsibilities

    The Lead Mechanical Engineer will be a member of the Product Development staff and be involved in the design, development, and maintenance of new MRI compatible products.

  • Responsible for the mechanical design of future generations of MR Patient Care products
  • Coordinates and mentor junior engineers in research, design, development, and implementation of product architerctures
  • Connect and align with project management on project content, timeline and costs
  • Responsible for requirements, design, implementation, test and integration of module/sub-system in accordance with the higher level requirements and specifications
  • Conduct concept & feasibility studies. Lead the introduction of new technologies
  • Act as mechanical lead to review and provide oversight of R&D activities (i.e. internal and external support) developing products for the MRI.
  • Oversee compliance and V&V activities, including offsite test management.
  • Lead design reviews, FMEA analyses, and other DfX related activities.
  • Review and ensure adequacy of supplier qualification activities.
  • Analyze technical issues using methodical problem solving techniques and provide root cause / solutions where required.
  • Actively participate on cross-functional/cross-business project teams through all phases of product development to ensure successful execution of innovative, best-in-class designs.
  • Network with colleagues within BU and beyond and maintain external contacts for benchmarking, new technologies, tooling, design methods, and reflects them to the HW-group
  • Draws up personal schedule and reports on progress

    • We are looking for

    The successful candidate will possess the following knowledge, skills education and experience:

    Essential Requirements

  • Bachelor of Science degree required, (Masters of Science preferred) with a concentration in an engineering discipline.
  • At least 10 years of engineering design experience.
  • Experienced in designing mobile and portable electronic enclosures.
  • Familiarity with Current ISO standards family that apply to medical devices.
  • Ability to interface with internal stakeholders and be effective at managing suppliers.
  • Experienced in design of die castings, injection moldings, machinings and sheet metal.
  • Experience in using Finite Element Analysis (FEA) programs to analyze designs for static and dynamic stresses.
  • Experience in using 3D Parametric tools (Creo, Solidworks, etc.).
  • Knowledgeable of ASME Y14.100 Engineering Practices.
  • Proficient in Geometric, Design and Tolerancing (GD&T) principles.
  • Experience with design reviews based on failure modes (DFMEA)
  • Experience with design of experiments (DOE)
  • Experience with requirements deconstruction from subassemblies to components.
  • Experienced in rapid prototyping techniques (CNC Machining, 3D Printing, Sheet Metal, etc.)
  • Ability to understand and debug problems across hardware / software / system boundaries

    • Desirable

  • Class 2 or Class 3 medical device development experience.
  • Understanding of global regulatory requirements for medical devices.
  • LEAN/Six Sigma certification or experience.
  • Familiarity with risk management through a full product development cycle from requirements to validation.
  • Experience with DOORS requirement management tool and Creo 3.0.
  • Experience in the field of Medical Devices product design e.g. CT, MR, X-Ray, Mammography systems etc. will be an added advantage
  • Exposure to International Medical Quality and Regulatory Standards e.g. IEC, FDA, UL, CE is a plus

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