Skip to content

Senior Mechanical Design Engineer

United States, Texas, AustinEngineering

Job description

About Nuclein:

Nuclein is an Austin-based, private equity funded company working to commercialize a disposable, hand-held, sample-to-answer, battery-powered PCR testing device. Our platform uses real-time, RT-PCR, requires no technical expertise to operate, and delivers on-the-spot results in under one hour. Please visit Nuclein.com/demo for more details.


Our vision is to enable simple, affordable, rapid, and accurate disease testing for everyone. We are a dedicated, talented, and diverse team of scientists, engineers, and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, dynamic, collegial environment, where individual contributions are highly valued.


Please visit Nuclein.com for more information about our company’s history, technology, and vision.


Position Summary:

The Senior Mechanical Design Engineer will have a central role in leading the mechanical design efforts for next-generation molecular diagnostic devices as a member of the Engineering Department. The primary responsibility will be to develop novel approaches to product design for manufacturable and reliable products, including designing product mechanical components for volume manufacturing that meet operational requirements.

Job requirements

Primary Responsibilities:

  • Work with internal teams (Engineering, Biology, Chemistry, Operations, Quality, Marketing, etc.) and external vendors to optimize production and product performance
  • Develop and document methods, procedures, and processes for product design
  • Troubleshoot and solve complex component and system-level problems
  • Draft verification and validation test cases as it applies to product design
  • Work with Contract Manufacturer on product transfer to manufacturing environment
  • Perform other duties as assigned

Qualifications:

  • Bachelor of Science in Mechanical, Aerospace, Biomedical or related field, or equivalent years of education and experience required
  • At least 7 years of engineering experience
  • Experience developing products for industrial or commercial use
  • Knowledge of, and experience with, materials for volume manufacturing designs
  • Experience designing injected molded plastics for moving small amounts of fluid around
  • Demonstrated experience interfacing with volume manufacturing suppliers for components, plastics, rubber, and/or metal fabricated components
  • Proven expertise with SolidWorks
  • Demonstrated proficiency with GD&T
  • Experience with process development, mapping, and optimization
  • Working knowledge of industry standards and regulations (UL, CE, RoHS, ISO, etc.)
  • Experience with design/development of medical IVD products or components for 510(k) submission preferred
  • Experience with risk analysis and FMEA development preferred
  • Six Sigma and/or Lean certification preferred
  • Experienced expertise in working under ISO 9001, ISO 13485, 21 CFR 820 preferred
  • Experience working with complex PCB/Flex assembly routing and cable management preferred
  • People management experience preferred
  • Ability to operate efficiently with a high level of attention to detail, with minimal supervision, while working within a team
  • Ability to safely lift 50 pounds

or