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Senior Test Development Engineer

United States, Texas, AustinEngineering

Job description

About Nuclein:

Nuclein is an Austin-based, private equity funded company. 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.


We are commercializing a disposable, hand-held, sample-to-answer, battery-powered PCR testing device, with current focus on development of a COVID-19 test. 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.


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 product vision.


Position Summary:

The Senior Test Development Engineer will be integral to supporting the development and manufacturing of next-generation molecular diagnostic devices as a member of the Engineering R&D Department. The successful candidate will develop test methods, infrastructure, and support for all aspects of manufacturing transfer and commercial production of components and products, including developing and documenting methods, procedures, and processes to achieve go-to market initiatives.

Job requirements

Primary Responsibilities:

  • Work with internal teams (Design Engineering, Biology, Chemistry, Operations, Quality, Marketing, etc.), the Contract Manufacturer’s engineering team, contractors, and external partners to optimize production and product performance
  • Troubleshoot and solve complex component and system-level problems
  • Develop methods for identifying non-conforming materials and product issues
  • Draft and execute verification and validation test cases
  • Identify previously unknown process variables and implement solutions
  • Perform duties in a clean room environment
  • Perform other duties as assigned


Qualifications:

  • Bachelor of Science in in Mechanical, Electrical or related field, or equivalent years of education and experience required.
  • 7-10 years of engineering or related relevant experience
  • Knowledge of ISO 9001, 13485, 21 CFR 820 a plus
  • Familiarity with FDA standards a plus
  • Demonstrated experience with process development, mapping, and optimization – including DOE development and execution
  • Demonstrated experience with SolidWorks, Altium PCB Designer, or equivalent design software
  • Familiarity with firmware development environments a plus
  • Experience with failure investigations
  • Experience with FMEA development
  • Demonstrated experience with product and process verification and validation
  • Knowledge of materials, including: metal fabrication and plastics molding techniques
  • Experience with test method development
  • Proven 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
  • Ability and willingness to work outside of normal business hours as needed
  • Ability and willingness to travel domestically and internationally

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