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  • Job Title
  • Senior Mechanical R&D Engineer
  • Location
  • Irvine
  • Job Number
  • 119449
  • State
  • California
  • Job Class
  • Contract/Temp
  • Category
  • Engineering
Job Description

Growing, fast paced medical device company focused on ground-breaking technologies for patients with respiratory diseases. Located in South OC and recently moved into a large new facility where they are moving forward with the industry's first wearable ventilator! This work environment offers employees opportunities to grow that are not available in some larger organizations.

Position Summary:

  • This position reports directly to the VP of R&D and is responsible for creating mechanical designs for new and existing ventilation products from concept to production within an FDA regulated quality system.
  • The position will design both capital and consumable medical devices and sub-assemblies.
  • The candidate will work in a team environment and will work closely with electrical, software, and systems engineers as well as with manufacturing and quality.
  • The candidate will contribute to the technology and product road mapping process while facilitating engineering process and initiatives.
  • The candidate will provide technical guidance for new product designs, optimization and problem solving.


  • Design pneumatic systems and subsystems based on a good understanding of fluid mechanics. This includes systems that have flow control, pressure control, compressors, O2 concentrators, as well as associated consumables.
    • Design mechanical enclosures and sub system assemblies.
    • Provide technical support for the other engineering disciplines including electrical, software, quality and manufacturing engineers.
    • Ensure that designs meet industry and regulatory standards.
    • Conduct various tests to verify and validate design capabilities.
    • Assist in research and development of new products.
    • Provide guidance on designs to meet testing requirements.

Required Skills and Experience:

  • Bachelor’s Degree in Mechanical Engineer or equivalent engineering discipline, a Master’s Degree is highly desired.
  • 10 plus years of experience designing medical device or devices in other regulated industry.
  • Experience with Solidworks and PDM Works
  • Experience with FDA GMPs and ISO 13485
  • Knowledge of EN60601-1, ISO 10993, RoHS & REACH
  • Experience with managing requirements, configuration, issue tracking tools, etc.
  • Demonstrated leadership abilities in test and issue ownership.
  • Provide guidance and mentoring to others.
  • Self-motivated, deadline oriented, detailed and able to work in a fast paced environment.

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