Manufacturing Manager - Instrument

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.    

Essential Duties and 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.

·         Monitor and manage department costs

Education, Qualifications, and/or Experience. 

·         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 required

·         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.

·         Experience in using/navigating ERP systems

·         Proficient with Microsoft Office Suite or related software to complete reports and logs.

Physical Requirements. 

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: at least 25 lbs

·         Position: Mostly sitting

·         Speaking and communicating