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

DesignPlex Biomedical LLC

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