Lean Manufacturing Engineer

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 Lean Manufacturing Engineer is responsible for providing engineering expertise in the areas of new product development, process development and improvement, equipment and sustaining engineering, manufacturing technologies, and project support to assure the production of World Class products. This position is a Lean leader within the company. The Lean Manufacturing Engineer must take a proactive approach to the performance of job assignments with minimal input supervision. Requires excellent problem-solving skills including equipment troubleshooting, process debugging through data analysis, implementation of alternate manufacturing techniques, and innovation that improves product and process efficiencies. This position requires moderately complex decision make at a level that can affect overall manufacturing efficiency, which may impact direct cost margins.

This Position will be located onsite in Carlsbad, CA.

• Provide functional leadership with awareness, knowledge and guidance of Lean principles, methodologies and tools to support QuidelOrtho facility objectives.

• Coach, train, and mentor cross-functional teams in proper use and application of Lean or Six Sigma tools, including, but not limited to Standard Work, 5S, Kanban, GEMBA, etc.

• Provide production floor and assembly support in technical matters relating to assembly drawing interpretation, Engineering change Notices, rework, manufacturing difficulties and specifications.

• Compile and evaluate test and production data, prepare technical analysis, and recommend manufacturing methods and processes required to meet design objectives on new or improved products and/or processes.

• Coordinates with other technical support personnel.

• Maintains integrity of Manufacturing Instructions (MIs).

• Approves Manufacturing routings and BOMs, executes changes as required.

• Maintains equipment status, operating condition, and operating procedures (EINs).

• Designs workstation layouts, equipment required, access to tools, storage of tools and equipment.

• Monitors material and process flow through the work areas.

• Troubleshoots proprietary machinery and processes.

• Performs capacity analysis.

• Communicates cross-functionally with individuals and departments regarding manufacturing operations.

• Writes and executes equipment validation protocols.

• Develops operator training protocols and assists in operator training.

• Develops and implements MFG documentation or new products and processes.

• Communicates with area manager, lead, supervisor, QE, and product improvement groups.

• Monitors equipment set-ups, documentation, and operating parameters, including identifying and arranging for new equipment acquisitions.

• Processes yield and scrap.

New Product Development

• Develop manufacturing strategies to support the transfer of products from R&D to production and ensure product specifications are consistent with standard raw materials and manufacturing processes.

Lean Six Sigma

• Apply lean six sigma methodology to lead continuous improvement of processes through Kaizen events. Establishes cross-functional team including key stakeholders to foster collaborative problem solving. Knowledge and application of range of problem solving tools to drive effective problem-solving from problem statement through countermeasure sustainment.

Equipment Engineering

• Generate equipment specifications defining machine performance criteria that are quantifiable by SPC and FEMA analysis. Develop new equipment strategies and generate documentation to support procurement of capital equipment. Develop manufacturing control plans and metrics that verify machine outputs are compliant with QSR standards. Support machine-build activity through regular design reviews and milestones. Install and validate existing and new equipment, generate equipment operating instructions and conduct operator and maintenance training.

Sustaining Engineering & Process Improvement

• Apply engineering techniques to sustain and maximize current manufacturing efficiencies. Areas include wet chemistry processing and filling, automated and manual assembly. Identify and implement new

• technologies and continuous improvement to optimize manufacturing process output. Develop and maintain Manufacturing Instructions, SPC, Routings and Bill of Materials. Perform analysis, testing and qualification as required to support raw material and part configuration changes. Identify process control points and implement appropriate process control parameters.

Project Support

• Manage and / or provide engineering guidance for cross-functional project teams functioning at either the team leader or team member capacity. Generate project plans and timelines using Microsoft Project. Organize and manage team meetings, generate agendas and write meeting minutes. Responsible for meeting all team objectives.

Documentation

• Generate documentation for production operations including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans. Maintain and generate new item information and routings per ERP requirements. Submit documents and create ECO's for any new and existing product and processes per Document Control guidelines.

• Carries out duties in compliance with established policies

Required:

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience.

• Minimum two (2) years' experience in medical device, diagnostics or pharmaceutical environment.

• Minimum two (2) years of experience with Six Sigma / Lean Manufacturing, ideally as a Green Belt or equivalent.

• Demonstrated advanced problem-solving.

• Excellent verbal and written skills.

• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in Electrical-Mechanical Theory & Application, Process and Assembly Automation, 2D & 3D CAD, Hardware Design, Pneumatics, Instrumentation, PLC and Machine Programming, Basic Finance Theory, and basic quality tools.

• Implementation of continuous improvement projects to improve the productivity and delivery of products on time to achieve business targets on a daily basis.

Internal Partners:

Scientists, Production Managers, and Marketing Representatives, as well as the Finance, Maintenance, Facilities, Planning and Materials departments.

External Partners:

Suppliers

The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines.

Position requires ability to lift up to 25 lbs., work within restricted areas confined by equipment. Up to 50% of time/work within a low humidity environment with potential exposure to biological, toxic and corrosive reagents; and up to 50% is required to work within the confinements of a cubical style office, and also within a laboratory setting. Walking, standing and sitting for longs periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be willing to work 1st or 2nd shift. Position requires use of Personal Protective Equipment as posted.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $108,000 - $120,000 annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 recruiting@quidelortho.com.

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