Manufacturing Engineer (Instrument)
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 Manufacturing Engineer (Instrument) provides technical support to Nuclein cGMP manufacturing operations. This role will focus on instrument production. interfacing directly with Quality Assurance, Production personnel, Supply Chain, Engineering and Assay Development to ensure the on-time delivery of high-quality devices in line with company growth and supply demands.
Responsibilities:
- Lead and manage manufacturing engineering activities such as validations, test equipment design, test procedure development, process development and automation equipment implementation.
- Work with Development groups for the implementation of engineering changes to the manufacturing process
- Monitor production metrics and implement proactive corrective actions and process efficiency improvements as needed.
- Develop equipment, fixtures and tools that are needed for the manufacturing process.
- Ensure strict adherence to FDA regulations and GMP guidelines through process development and oversight.
- Resolve CAPAs and product Non-Conformances for the factory floor including supporting MRB functions
- Support 3rd party compliance audits.
- Provide technical support for Design for Manufacturability and product changes
- Foster a culture of teamwork, accountability, and continuous improvement.
- Develop Manufacturing Instructions as required. Including training to Direct Labor as needed
- Develop and train processes to improve compliance and accountability such as Line Clearance and Label Line Clearance
- Implement lean manufacturing principles to streamline operations.
- Support development and direct support of instrument assembly manufacturing lines identifying needed equipment and test fixtures. Including process development, maintenance, training, and monitoring
- Work directly with suppliers to resolve Materials issues.
- Develop BOMs, routings and other manufacturing process documentation as required
- Support returned product rework and repair including work instruction and test procedure development
Qualifications:
- Bachelor’s degree in a relevant field
- 3+ years of experience in manufacturing engineering support responsibilities in the medical device industry. Specifically in instrument manufacturing is desired.
- Experience operating in environments of FDA regulations and cGMP guidelines such as CFR820 and ISO13485-2016 is desired.
- Excellent problem-solving and decision-making skills.
- Demonstrated ability to drive process improvements and cost reductions.
- Ability to work collaboratively, explain the ‘Why,’ and be able to influence others in a fast-paced environment
- Ability to operate independently with moderate supervision
- Possess a high level of attention to detail and organization
- Ability to prioritize tasks and to delegate them when appropriate
- Proficient with Microsoft Office Suite or related software to complete reports and logs
- Must be able to traverse the facility
- Must be able to lift 25 pounds at a time