Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

The Lead Process Engineer is responsible for advancing the sites manufacturing capabilities by developing new processes and systems and by providing technical leadership to all areas of manufacturing. Additionally, the role will ensure legacy product lines are continuously improved and new product lines transition smoothly into full production, all while adhering to financial and schedule commitments. The Senior Manufacturing & Process Engineer will over see equipment selection, installation, validation, maintenance, and calibration requirements.

• Proposes, justifies, and manages large scale improvement projects with a significant business impact involving processes, products, and equipment enhancements.
• Considered a subject matter expert. Keeps informed of new technological developments that may affect the organization.
• Introduces relevant modern technology and methodology to manufacturing operations.
• Provides advanced technical manufacturing expertise to all levels of the organization.
• Support Lean initiatives through robust engineering and leadership on goals such as 5S, Value Stream Mapping, Kaizen, helping to implement the changes, and measuring the results.
• Function as a lead resource for New Product Development activities, designing for manufacturability and supporting the product lifecycles.
• Drive preventative maintenance process improvements and system development.
• Manage budgets and equipment purchase and installation for large scale and/or high impact projects.
• Execute safety, ergonomics and production risk assessments as required for business goals.
• Lead and coach others in the use of advanced Six Sigma tools to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimize process variability.
• Collaborate with program development on new product launches and product transfers to manufacturing. Develop and conduct Factory Acceptance Tests and equipment validation ensuring a high degree of process capability.
• Responsible for all necessary documentation and approvals; standard operating procedures, work instructions, and assist with related training.
• Collaborate and partner with various departments to investigate and troubleshoot process or equipment issues, and to implement specific corrective actions using PFMEA, root cause analysis, and other risk management methodologies.
• Oversee development and implementation of timely, economical, repeatable, validated, mistake-proof manufacturing processes and controls for new and legacy products.
• Must be able to concentrate, analyze, and solve complex issues throughout the workday.
• Ability to sit and stand for long periods, sto
• op, reach, bend throughout the workday.
• Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the workday.
• Ability to travel by air/car to other locations of MBI as needed.
• May, if required, carry a cell phone to facilitate intra-department communications both during and after normal business hours.

• Requires a Bachelor’s degree in a Science or Engineering field. Master’s degree (MS) is preferred.
• A minimum of 8-10 years of experience in manufacturing engineering, industrial engineering, process improvement, manufacturing quality or design transfer.
• Previous experience in an FDA regulated production environment
• Strong background in good manufacturing practices and ISO requirements
• Strong background in equipment design, requirements for equipment maintenance and maintenance procedure development.
• Ability to work in a fast-paced environment with multiple priorities
• Exemplary verbal and written communication and organizational skills
• Ability to work with a team or independently with minimum supervision
• Training and experience in testing and troubleshooting electromechanical assemblies.
• Familiar with good laboratory practices
• Demonstrated knowledge in advanced problem-solving methods and determining root cause through understanding and use of lean and six sigma tools.
• Leadership experience in design of experiments and engineering controls.
• Flexibility to work eight plus hours/day, including the ability to work weekends, and other shifts/hours as needed to meet production schedules.
• Ability to work independently with little direction.
• Able to prioritize multiple tasks from multiple sources.
• Highly organized.
• Proficient in Solidworks
• Experience in AutoCad 

Salary Range: $130,000-$150,000

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*