Manufacturing Manager (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 Manager (Instrument) will lead Nuclein’s instrument manufacturing and instrument repair depot processes. The individual will be responsible for overseeing and managing the performance of all aspects of the manufacturing process, ensuring compliance with FDA regulations and GMP guidelines, and driving continuous improvement initiatives to optimize efficiency and product quality.

Responsibilities:

• Manage instrument and instrument repair depot manufacturing processes ensuring adequate resources, manufacturing capacity and planning as well as hiring and managing the direct labor and test technician operations
• Develop and implement required cGMP production processes and procedures.
• Develop and support production metrics and implement corrective actions as needed.
• Ensure strict adherence to FDA regulations and GMP guidelines through audits and daily oversight.
• Develop training documentation and plans for assembly team members.
• Collaborate with the Quality Assurance and Quality Control teams to address quality issues.
• Identify facility and equipment needs including oversight of facility projects and equipment installations.
• Identify opportunities for process optimization and efficiency improvements.
• Implement lean manufacturing principles to streamline operations.
• Lead continuous improvement projects.
• Oversee inventory levels to support production schedules
• Work with Commercial group to develop forecasts and production schedule.
• In line with company growth, hire, supervise and mentor a team of assembly personnel.
• Foster a culture of teamwork, accountability, and continuous improvement.
• Conduct performance evaluations and provide coaching to team members.
• Promote a safe working environment by enforcing safety protocols. Investigate and report safety incidents, implementing preventive measures.

 Qualifications:

• Bachelor’s degree in a relevant field, or equivalent years of education and experience required.
• At least 5 years of experience in manufacturing operations or equivalent role(s), preferably in the medical device industry.
• Experience operating in environments of FDA regulations and GMP guidelines preferred
• 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.
• Ability to work cross-functionally to ensure all manufacturing objectives are met.
• 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.