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:
Education:
Experience:
- Solidworks: 5 years (Preferred)
- Medical Device: 10 years (Required)
Work Location: In person
