Senior Manufacturing Engineer
United States, Texas, AustinEngineering
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.
The Senior Manufacturing Engineer will be integral to supporting the manufacturing and development of next-generation molecular diagnostic devices. Reporting directly to the Senior Director of Systems Engineering, this individual will be responsible for supporting all aspects of manufacturing transfer and commercial production in cooperation with our contract manufacturer (CM). This role will require a significant amount of international travel and will focus on troubleshooting and solving complex component and system-level issues.
- Support all aspects of manufacturing transfer and commercial production
- Develop and document manufacturing processes
- 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
- Investigation, documentation, and review of non-conforming materials and product
- Draft and execute verification and validation test cases
- Work with Contract Manufacturer partner to implement and maintain best practices and manage corrective actions
- Interact with Contract Manufacturer and other teams outside of normal business hours as required
- Identify previously unknown process variables and implement solutions
- Perform duties in a clean room environment
- Perform other duties as assigned
- Bachelor of Science in Mechanical, Electrical or related field, or equivalent years of education and experience required
- At least 10 years of engineering or related relevant experience in complex manufacturing environment required
- Knowledge of ISO 9001, 13485, 21 CFR 820
- Familiarity with FDA standards preferred
- Lean/Six Sigma certification preferred
- Experience with microfluidics, thermal characterization, heat and mass transfer, electrical schematics, PCB design/review, and/or SPC preferred
- Demonstrated experience with process development, mapping, and optimization – including DOE development and execution
- Demonstrated experience with SolidWorks
- Demonstrated experience with failure investigations
- Excellent technical writing skills
- Demonstrated experience with product and process verification and validation
- Experience with FMEA development
- Knowledge of materials – plastics, metals, adhesives, thin films
- Test method development experience – including MSA and Gage R&R
- Ability to operate efficiently with a high level of attention to detail, with minimal supervision, while working with a team
- Work effectively in remote vendor locations
- 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 up to 75%