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Lean Manufacturing Engineer

2 months ago

Carlsbad, United States QuidelOrtho Full time

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 As we continue to grow as QuidelOrtho, we are seeking a Lean Manufacturing Engineer to support our Engineering Operations team. The 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 will be working onsite at our Carlsbad (Rutherford) location in San Diego, Ca. The Responsibilities 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. Generate equipment specifications defining machine performance criteria that are quantifiable by SPCand 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. 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. 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. 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. Perform other work-related duties as assigned. The Individual Required: BS degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience. Two to five years' experience, preferably in a pharmaceutical or medical device environment. The Manufacturing Engineer must take a proactive approach to the performance of job assignments with minimal input from supervision. Strong problem-solving skills include equipment troubleshooting process debugging through data analysis, implementation of alternate manufacturing techniques and innovation that improves product and process efficiencies. This position requires decision making to a level that can affect overall manufacturing efficiency, which may impact direct cost margins. Problem solving and decision-making skill requirements are outlined as follows: Must be able to resolve moderately complex technical problems independently and progressively gain the sills to solve complex problems with minimum supervision. 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, basic quality tools, advanced problem solving, excellent written skills. The Key Working Relationships Internal Partners: Perform cross-functional tasks that require the individual to interact with members from all departments at various levels within the organization. Primary customers include Scientists, Production Managers, and Marketing Representatives, as well as the Finance, Maintenance, Facilities, Planning and Materials departments. Interaction activity involves providing engineering expertise with deliverables in the form of formal reports and presentations, data analysis, new equipment and process implementation, and improved product and platform configurations. The Work Environment 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. No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel. Salary Transparency 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 $90,000 to $110,000. 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. Equal 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 the 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 .