About Nuclein:
Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.
Our vision is to enable simple, affordable, rapid and accurate 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, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.
Please visit Nuclein.com for more information about our company's history, technology, and vision.
Position Summary:
The Mechanical Engineer will play a pivotal role in the design, development, support, and validation of mechanical systems for Nuclein’s technologies. The individual will be responsible for leading the mechanical design process, ensuring compliance with regulatory standards, and collaborating cross-functionally to integrate mechanical components seamlessly into the technology and systems.
Responsibilities:
- Leads the design and architecture of mechanical components, assemblies, and interfaces for Nuclein's devices.
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Ensures that designs meet specifications, performance targets, and regulatory requirements.
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Designs and prototypes intricate mechanical components using CAD tools, ensuring precision and adherence to design standards.
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Collaborates with cross-disciplinary teams to integrate mechanical components with electronic systems.
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Operates within an FDA-regulated environment, ensuring all mechanical design activities adhere to relevant regulations and standards.
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Contributes to the preparation of documentation for regulatory submissions related to mechanical systems.
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Participates in the validation and verification processes, ensuring mechanical systems meet FDA and safety agency requirements.
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Leads and participates in investigations related to on-market products, identifying root causes of mechanical issues and implementing effective resolutions in compliance with regulatory requirements.
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Conducts thorough testing and validation of mechanical systems, identifying and resolving issues to ensure product reliability and safety.
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Participates in the selection of key mechanical components and suppliers, considering factors such as quality, availability, and cost-effectiveness.
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Drives continuous improvement in mechanical design processes, documentation, and testing methodologies to enhance efficiency and product quality.
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Stays current with industry trends, emerging technologies, and regulatory standards relevant to mechanical systems in medical devices.
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Supports Operations and the deployment of manufacturing equipment.
Qualifications:
- Bachelor's degree in mechanical engineering or a related field.
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At least 3 years of proven experience in the design and development of complex mechanical systems, preferably within the medical device or diagnostic industry.
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Proficiency in CAD tools (e.g., SolidWorks, AutoCAD) and familiarity with simulation tools.
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Knowledge of regulatory compliance and standards in the medical device industry (ISO 13485, FDA regulations).
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Strong problem-solving skills with the ability to troubleshoot and debug complex mechanical systems.
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Effective communication and collaboration skills, with the ability to work in interdisciplinary teams.
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Strong attention to detail and commitment to producing high-quality, reliable products.