Staff Engineer, Mechanical R&D

Position Overview

Support the design and manufacture of medical devices, including creating 3-D designs using a design software such as SolidWorks, generating detailed 2-D drawings, writing engineering requirements, developing test methods and designing test fixtures, supporting product manufacturing and problem solving issues through design, development, design transfer launch and post market phases.

Work closely with R&D counterparts, Operations, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue supporting product sustaining. Job duties:
  • Work in cross functional teams to identify customer needs and develop system requirements, specifications, designs, and drawings to meet these needs.
  • Ability to translate abstract ideas into design solutions using variety of methods including but not limited to simple hand sketches, 3D models, mock-ups and prototypes.
  • Communicate technical concepts effectively to non-technical team members to facilitate cross functional understanding.
  • Develop test plans, protocols, and reports as part of design verification and validation.
  • Develop designs that are robust and optimized for manufacturability.
  • Evaluate different design solutions and components to determine optimum solution for the application.
  • Develop and test protypes as required during the course of product development.
  • Release revision-controlled designs and documentation in document control system.
  • Support the design transfer of product from R&D to Manufacturing for volume production.
  • Train Technicians to assemble and test mechanical systems.
  • Develop and maintain vendor relationships.
  • Assist with solving technical challenges encountered during manufacturing.
  • Support post market sustaining efforts (i.e. complaint investigations, product training).
  • Perform additional duties as assigned.

Job Details

    1. Bachelor’s Degree in Mechanical Engineering.
    2. Eight (8) to ten (10) years of relevant product development experience.
    3. Ability to communicate effectively (both written and verbal) in English.
    4. Experience designing complex mechanical/electromechanical systems.
    5. Experience designing enclosures, chassis, and spatial packaging of components.
    6. Working knowledge of fundamental mechanical engineering principles including Fluid Mechanics, Strength of Materials, Statics and Dynamics.
    7. Strong design expertise using SolidWorks including ability to generate complex designs with clean and organized design history, detailed 2D drawings and BOMs.
    Desired Qualifications
    1. Advanced Degree in Mechanical Engineering.
    2. A minimum of six (6) years of medical device experience.
    3. Experience designing components optimized for injection molding.
    4. Experience with developing user centric industrial designs for medical devices.
    5. Experience with Finite Element Modeling.
    6. Working knowledge of medical devices and FDA regulations.
    7. Experience with CAPA systems, including complaint handling.
    8. Ability to receive the appropriate inoculations required to enter an operating room environment.