About The Position

Primary Function of Position Intuitive Surgical designs and manufactures highly complex mechanical systems for use in surgery. These systems include both capital equipment and “consumables” in the form of surgical instruments and accessories. The senior mechanical engineer for Stapling Instruments will be a lead member within a team responsible for product improvements and sustaining of currently marketed instruments in the field. The candidate will have both the technical depth to resolve complex mechanical, materials, and manufacturing design issues and the ability to work in an interdisciplinary team to troubleshoot and establish root cause of higher-level system issues. A proven sense of shared responsibility and shared reward is required as well as a commitment to high product quality. The candidate will brainstorm, identify and evaluate new technologies and mechanical designs in light of customer and company needs, collaborate with suppliers to realize viable technical solutions, refine designs for existing product, and inform and implement design solutions for new products. The successful candidate must excel in a high-energy team environment and be capable of creative problem solving.

Requirements

  • High proficiency using software like 3D CAD to design mechanisms; SolidWorks preferred (3D design & surfacing), Matlab, Finite Element Analysis (such as Ansys/Simulation)
  • Comfortable with all phases of the product development lifecycle, including design, implementation, debugging, verification, qualification, and transfer
  • Excellent analytical aptitude with an emphasis on theoretical fundamentals, experimental design, and data analysis
  • Proficiency at failure analysis, including root cause analysis techniques (e.g., fishbone, 5 Whys, etc.)
  • Solid understanding of component selection criteria and design for reliability and manufacturability
  • Demonstrated knowledge of component manufacturing processes such as high-volume injection molding, machining, MIM, and heat treatment; Experience collaborating with manufacturers to optimize component DFM and DFA.
  • Understanding concepts of design input, design output, requirement traceability, and FMEA risk analysis
  • Ability to communicate effectively (written and verbal) across functions, including presenting to a technical audience
  • Demonstrated ability to create and execute an engineering test plan, and proficiency at writing engineering test reports
  • Comfortable operating machine shop, measurement, and test equipment
  • Project Management experience a plus
  • Minimum BSME with at least 6 years experience, MSME with 3 years experience, or PhD with 1 years experience

Nice To Haves

  • Prior experience working in a regulated industry (medical device strongly preferred)
  • Mechanical analysis, including statics, dynamics, and strength of materials
  • Familiarity with sterilization processes and designing for biocompatibility
  • Experience in process development and assembly instructions
  • Programming in Matlab to interface with electromechanical assemblies and perform data analysis

Responsibilities

  • Design, develop and document components and assemblies for surgical instruments
  • Conceptualize and evaluate complex assemblies, create theoretical models, conduct empirical confirmation, and perform computer-assisted simulations
  • Design and develop mechanical parts and assemblies, with careful consideration for mechanical design, materials (plastics & metals), and stress analysis
  • Develop product design specifications and perform DFMEA on designed parts
  • Collaborate with supplier engineers and vendors to optimize component DFM
  • Create and maintain engineering drawings to company and international drafting standards
  • Perform technical design reviews to solicit feedback on design progress
  • Participate in clinical lab testing to understand product’s performance; implement clinical feedback into product’s requirements and design.
  • Develop and perform verification and validation testing
  • Guide projects through the design control process (risk analysis, design specification, design review, etc.) and support manufacturing personnel in builds (procurement, assembly, troubleshooting)
  • Provide mechanical engineering sustaining support for resolution of manufacturing and field issues
  • Investigate and establish root cause of both latent and emerging design, manufacturing or material defects
  • Assess field reliability data and improve existing product designs as necessary
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