Sr. Mechanical Engineer

4 weeks ago


Houston, United States Lumicity Full time

Senior Mechanical Engineer


My client is looking for a Sr. Mechanical Engineer to perform research and development activities for endovascular guidewires/catheters for their Houston offices. This company serves a global network of hospitals and medical facilities in a 100+ countries with a growing team of 1,000+ employees.



Job Functions

  • Conducts research and development activities
  • Conducts technical risk management activities, proof of concept design, prototype design and testing in accordance with design verification and validation requirements
  • Develops and improves manufacturing processes
  • Manages the adherence to procedures to ensure product quality meets or exceeds planned goals
  • Develops and executes design verification and design validation protocols and reports
  • Assures product and process quality by designing testing methods; testing finished product and process capabilities, establishing standards, confirming manufacturing processes
  • Is aware of and complies with regulatory requirements (21 CFR 820, ISO 13485)
  • Participates in quality control/assurance related activities



Essential Requirements

  • Bachelor’s Degree in Mechanical, Biomedical, Materials Engineering or related
  • 5-10 years of experience in the medical device industry in R&D setting
  • R&D experience with endovascular guidewires and catheters, preferably steerable guidewires
  • SolidWorks CAD experience
  • Ability to articulate clearly, professional oral and written communication skills
  • Must be proficient in general computer programs such as Microsoft Office
  • Strong planning, technical, and problem-solving skills
  • Ability to understand and create engineering schematics
  • Familiarity with ISO 13485, 21 CFR Part 820 QSR.



Location

Houston, TX


If you're interested in hearing more about this position and company, please send an updated resume to Patrick.Kelly@lumicity.io



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