Manufacturing Engineering Manager

Position Summary.

The Manufacturing Engineering Manager will lead the engineering efforts in support of Nuclein’s  instrument and cartridge manufacturing, instrument repair operations .   The individual will be responsible for overseeing all technical and product support aspects of manufacturing operation. Ensuring compliance with FDA regulations and GMP guidelines, driving continuous improvement initiatives to optimize efficiency and product quality while ensuring the successful completion of all corporate manufacturing initiatives.

Essential Duties and Responsibilities. 

·         Provide technical support for instrument, instrument repair and cartridge manufacturing operations.  Includes ensuring meeting all on-market production requirements as well as design transfer and NPI activities for new assay solutions.

·         Lead the development and implementation of production process and procedures such manufacturing instructions, manufacturing process development and validations.

·         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.

·         Collaborate with the Quality Assurance and Quality Control teams to address quality issues identified internally as well as supporting field complaints

·         Identify and implement facility and equipment needs including oversight of facility design projects and equipment installations and validations. Includes identifying new and/or replacement equipment and processes as well as supporting equipment maintenance.

·         Lead product nonconformance and CAPA resolutions

·         Interface with Suppliers to resolve supplier material issues

·         Support 3^rd Party audits

·         Support calibration and maintenance programs

·         Lead introduction of engineering changes to product to the manufacturing process

·         Develop and maintain BOMs and product Routings

·         Identify opportunities for process optimization and efficiency improvements.

·         Implement lean manufacturing principles to streamline operations and update and maintain product routings and costing information

·         Identify and lead continuous improvement projects.

·         Conduct performance evaluations and provide coaching to team members.

Education, Qualifications, and/or Experience.

·         Bachelor’s degree in an engineering or life-science relevant field, or equivalent years of education and experience required.

·         At least 5 years of experience in technical manufacturing operations or equivalent role(s), preferably in the medical device industry.

·         Experience operating in environments of FDA regulations and GMP guidelines 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.

·         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

Physical Requirements.  

·         Repetitive Motion: Mostly computer use

·         Weight Lifting: at least 25 lbs

·         Position: Mostly sitting

·         Speaking and communicating