Manager, Production Engineering

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

The Manager, Production Engineering responsible for the development and implementation of engineering strategies and tactics supporting QuidelOrtho' s corporate objectives. This position functions as the primary facility subject matter expert while overseeing and managing daily engineering activities in support of the value streams manufacturing goals to meet overall company objectives. The role is instrumental in leading efforts such as new product development, process improvement, equipment reliability, capital projects, and ensures world class processes related to the accuracy and development of production data/technical information.

This role is located in Athens, Ohio.

The Responsibilities

• Provide strategic guidance and daily leadership for value stream engineering team (Process Engineering, Equipment Technicians, Automation Engineers, Technical Writer, and Production Data Specialist).

• Collaborate on root cause investigations and corrective actions throughout the manufacturing process as it relates to operational performance.

• Performs feasibility studies, scope development, capital requests (CERs), and oversees the execution of cost & capital projects within respective value stream.

• Oversight and execution of all asset management (financial tracking & reporting, calibrations, and related preventative maintenance [internal/contracted]) on all assets specific to the individual's respective business.

• Maximize process equipment availability/performance/quality and creates a metric (OEE) driven manufacturing environment targeted at identifying process trends and proactively implements continuous improvement initiatives to meet business objectives.

• Manages equipment design & reliability, process engineering, and data integrity from chemistry through final production assembly for respective value stream.

• Responsible for initiating and executing "existing" (repair/relocation) equipment validation protocols (IQ, OQ, PQ) and reports per (GSOP)

• Oversight of all data and technical documentation related to operations and ERP system. Which includes, integrity of established manufacturing Instructions (MI's), development and implementation of MFG documentation for new products and processes, including TMs (Test Methods), MIs (Manufacturing Instructions), development of equipment operating procedures (EOPs, SOP's, & JSP's) and changes per ECO process., and approve BOM's (Bill of Materials) manufacturing routings and execute changes as required.

• Initiate change orders relating to Equipment & Process Manufacturing Instructions and collaborates on initial protocol and revisions.

• Actively manages, and advises adjustments to LBE/AOP as needed, departmental expenses and manpower allocations within the site budget and to achieve strategic objectives.

• Defines and oversees the execution of the preventative maintenance strategy for respective (new and existing) assets.

• Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

The Individual

Required:

• Bachelor's degree, preferably in Engineering or Technical Life Sciences.

• 5+ years of demonstrated engineering experience in a manufacturing environment (i.e., equipment design, process development, and project management).

• Effective problem solving and excellent communication skills.

• Strong technical writing and analytical proficiencies, statistical process control capabilities, , ISO 9001 understanding, Design of Experiments knowledge, and sound capabilities in electrical-mechanical theory & application.

• Knowledge of advanced automation principles, ERP Systems, Engineering Change Order (ECO) process, and solid business acumen within a manufacturing environment.

• Superior leadership skills and technical knowledge to assist value stream in meeting departmental goals and objectives.

Preferred:

• 3-5 years of experience in a proven engineering leadership role

• Project Management experience / certification

• LEAN / Continuous Improvement experience / certification

The Key Working Relationships

Internal Partners:

Value Stream Engineering Team, Manufacturing Management (Production & Science), Quality, R&D / Supply Chain / EHS / CI / Finance / Facilities Management.

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines. May work with hazardous materials. Position requires ability to lift up to 50 lbs. on occasion. Up to 50% of time in meetings, working with team; 50% of the time at the desk on computer, walking, standing, or sitting extended periods of time, doing analytical work are routine to accomplish tasks in this role. Position requires use of Personal Protective Equipment as posted.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .

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