Biomedical Manufacturing Engineer

PMC Smart Solutions LLCShelbyville, IN
2hHybrid

About The Position

Perform biomedical engineering research, design, and development using biomedical engineering principles of implantable polymer-based biomaterial devices and disposable sterile surgical devices to be used in cardiovascular, ophthalmology, tissue biopsy, wound closure, trauma, women’s health, orthopedics, sports medicine, and spine device markets Develop statistical models and simulations of medical device components using computer software such as SolidWorks in order to test product physiological tolerance and ensure proper fit for respective medical industries, and prepare and present comprehensive findings to engineering design managers Provide biomedical engineering technical support and collaborate with manufacturing staff on the safety, effectiveness, and continuous improvements of the design, development, and manufacturing of medical device components Develop design verification and validation test protocols and execute physical testing of medical device components Analyze verification and validation test data, perform in-depth interpretation of results, and generate detailed technical reports while working with other biomedical engineers and scientists to design validation labs and conduct follow-up experiments, and research how engineering principles apply to biological systems Translate client-user needs and other client input into clear, concise medical device component design requirements and design concepts, as well as prepare for and conduct various design reviews in accordance with regulatory requirements In a non-supervisory capacity, provide biomedical engineering training, coaching, and guidance regarding medical device component project tasks to younger engineers, designers, technicians, and associates

Requirements

  • A Bachelor’s Degree in Biomedical Engineering, Bioengineering, or Chemical Engineering is required (a Foreign Educational Equivalent is acceptable).
  • Coursework (which may have been gained in Bachelor Degree program or higher degree program) must include demonstrated knowledge in the following computer software: SolidWorks.
  • This position requires incidental domestic travel (no more than one week per year) to supplier locations throughout the United States.

Responsibilities

  • Perform biomedical engineering research, design, and development using biomedical engineering principles of implantable polymer-based biomaterial devices and disposable sterile surgical devices to be used in cardiovascular, ophthalmology, tissue biopsy, wound closure, trauma, women’s health, orthopedics, sports medicine, and spine device markets
  • Develop statistical models and simulations of medical device components using computer software such as SolidWorks in order to test product physiological tolerance and ensure proper fit for respective medical industries, and prepare and present comprehensive findings to engineering design managers
  • Provide biomedical engineering technical support and collaborate with manufacturing staff on the safety, effectiveness, and continuous improvements of the design, development, and manufacturing of medical device components
  • Develop design verification and validation test protocols and execute physical testing of medical device components
  • Analyze verification and validation test data, perform in-depth interpretation of results, and generate detailed technical reports while working with other biomedical engineers and scientists to design validation labs and conduct follow-up experiments, and research how engineering principles apply to biological systems
  • Translate client-user needs and other client input into clear, concise medical device component design requirements and design concepts, as well as prepare for and conduct various design reviews in accordance with regulatory requirements
  • In a non-supervisory capacity, provide biomedical engineering training, coaching, and guidance regarding medical device component project tasks to younger engineers, designers, technicians, and associates
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