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DesignPlex Biomedical LLC

Senior Mechanical Engineer

DesignPlex Biomedical LLC, Fort Worth, TX, United States


Job description

If you’ve spent more than 10 years as a mechanical engineer in a highly regulated field and enjoy the challenges and opportunities of a growing entrepreneurial organization, this role is for you!

The person that takes this role will be mission critical for our organization and will be a strong contributor to a small team of highly experienced engineers who value integrity, work-life balance, and find true happiness in bringing ideas to life.

DesignPlex is specialized in development of electro-mechanical products for the medical field. Join us to be part of a world class team located in Fort Worth, Texas. This is a fun and exciting time for DesignPlex as we grow and make the newest products in medicine a reality.

Responsibilities:

  • Design development of mechanical systems for medical devices.
  • Perform detailed mechanical design of medical devices including sheet metal, injection molding, clean room fixturing, electromechanical integration and more through the use of Solidworks.
  • Conduct design analysis on components and/or assemblies to ensure designs are cost efficient, manufacturable, customer focused, and reliable.
  • Prepare technical data such as design verification test results, written work instructions, and device records to support production.
  • Maintain organized history of design artifacts utilizing a version control system.
  • Assist in preparing proposal documentation and integrate into customer specifications
  • Other duties as assigned.

Requirements:

  • 5+ years of mechanical design experience (or Masters Degree)
  • Bachelor’s degree in Mechanical Engineering or equivalent

Real world experience desired:

  • DFM/DFA for mechanical parts and assemblies
  • Sheet metal and injection mold experience
  • Design and test for compliance with regulatory standards (UL, FCC, etc.)
  • Design and test for industry ruggedness standards (shock and vibration, drop, IP, etc.)
  • Experience with engineering drawings and ASME Y14.5
  • Understanding of quality systems and regulations used for medical device design and manufacturing. (ISO13485 preferable)
  • Proficient in Design FMEA/FMECA and Design Verification and Validation activities with knowledge of medical electrical safety standards (60601-1, 60601-1-2, etc.)

Job Type: Full-time

Schedule:

  • Monday to Friday

Education:

  • Bachelor's (Required)

Experience:

  • Solidworks: 5 years (Preferred)
  • Medical Device: 10 years (Required)

Work Location: In person