Mechanical Engineer – Medical Device

Inspira Technologies is an innovative medical device company in the respiratory care industry. Inspira is developing the ART device, a cost-effective early extracorporeal respiratory support system with an intent to function as an “Artificial Lung” for deteriorating respiratory patients. The ART device is designed to utilize a hemo-protective flow approach aimed to rebalance saturation levels while patients are awake and breathing, potentially minimizing the patient’s need for mechanical ventilation.

The product is currently in a developmental stage and has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA).

For more information, please visit the company website:
https://inspira-technologies.com/.

We are now looking for a Mechanical Engineer to join us and be part of our inspiration.

Main responsibilities:

  • Mechanical design derived from specifications (as well as writing specifications), as part of a multi-disciplinary team of parts and assemblies. Presenting the design in technical design reviews at the levels of concept and detail design is a part of this position.
  • Developing creative design solutions in response to the product requirements of functionality, reliability, cost and manufacturability.
  • Building safety files for products, including strength calculations, failure modes analysis (FMEA), compliance with safety and medical industrial standards.
  • Supporting transfer to production, defining basic assembly and service instructions, working with parts suppliers,
  • Defining verification and validation test procedure, tests execution and report writing.

 

Essential qualifications/requirements:

  • 1st degree in Mechanical Engineering
  • Work experience of 3 years in mechanical design, with experience in at least 2 of the
    following: good knowledge of fluid dynamics, design structures and frames (chassis),
    mechanisms, electric packaging, electrical design support (DXF, cables routing)
  • Experience in machining and sheet metal technologies
  • Experience in prototype building (hands on), testing execution per test plan and
    failures troubleshooting
  • Experience in working at iso 13485 environment
  • Leading tasks from requirements to engineering change finalization
  • System level understanding in multi-disciplinary project environment
  • Definition of testing and report writing
  • Experience in design for cost, reliability, serviceability and for manufacturability
  • Ability to perform finite-element analysis and Excel level technical calculations
  • Good personal, teamwork and communication skills, willing to study, self-motivated, results oriented
  • Good English at presentation level in technical design reviews, and in writing

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