Mechanical Engineer in Irving, TX at HumCap Recruiting

Date Posted: 2/11/2021

Job Snapshot

  • Employee Type:
    Contract to Hire
  • Location:
    Irving, TX
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    2/11/2021

Job Description



Description:

The Mechanical Design Engineer will be responsible for design for electromechanical and disposable medical device systems. Provide medical device compliance knowledge, design expertise, technical competency, while contributing to a team designing and developing innovative mechanical and electro-mechanical medical devices or subsystems in a contract design and manufacturing environment. Work on cutting edge medical device products to design and implement innovative and cost-effective product solutions of complex scope in order to support the organization from early prototype development through full-scale production or anywhere in between. Responsibilities:Work independently and with a team of mechanical engineers to provide complete mechanical direction, technical expertise, coordination, and control of the activities necessary to design, document, fabricate, debug, and test both disposable and durable medical device products.To include but not limited to: product design, feasibility prototyping, risk management, technical design feasibility, tolerance stack analysis (TSA), stress analysis (FEA), fluid flow analysis, interface with tooling, mold flow analysis,  DF(x) analysis (design for … [assembly, reliability, cost, etc.]), design input development, design output verification plan, test method development support, support development of inspection requirements, metrology planning, working BOM development, suppliers/vendors, product data management (PDM/Agile), design reviews, planning, scheduling, technical writing, documented engineering testing, oversee engineering builds.Execute, collaborate, and bridge technical challenges with other cross functional engineering and support Translate customer requirements and convey in to testable mechanical requirement specifications (MRS).  Work with cross functional team to merge MRS into full system product requirement specifications (PRS).Perform risk analysis based on ISO 14971 Medical devices - Application of risk management to medical devices. Support presentation and execution of technical reviews and/or formal design reviews for mechanical systems/sub-systems. Required:Bachelor's Degree in mechanical engineering or related fields.15 + years of experience in the field or related area.Experience within a highly regulated environment (e.g. Medical, Aerospace, etc.).Proficient in SolidWorks, PDM and CAD file management software.Experience in DFX, FEA, and DFMEA.Knowledge of IEC 60601.Medical industry experience and familiarized with FDA and ISO 13485