Senior Manager, Engineering

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 Senior Manager, Engineering provides management and 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 located onsite in Carlsbad, CA.

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

• Generates equipment specifications defining machine performance criteria that are quantifiable by SPC and FEMA analysis.

• Develops new equipment strategies and generates documentation to support procurement of capital equipment.

• Develops manufacturing control plans and metrics that verify machine outputs are compliant with QSR standards.

• Supports machine build activity through regular design reviews and milestones.

• Installs and validates existing and new equipment, generates equipment operating instructions and conducts operator and maintenance training.

• Applies engineering techniques to sustain and maximize current manufacturing efficiencies. Areas include, but are not limited to, wet chemistry processing and filling, automated and manual assembly.

• Identifies and implements new technologies and continuous improvement to optimize manufacturing process output.

• Develops and maintains manufacturing instructions, SPC, routings and bill of materials (BOMs).

• Performs analysis, testing and qualifications as required to support raw material and part configuration changes.

• Identifies process control points and implements appropriate process control parameters.

• Manages and / or provides engineering guidance for cross-functional project teams functioning at the team leader or team member capacity.

• Generates project plans and timelines using Microsoft Project.

• Organizes and manages team meetings, generates agendas and writes meeting minutes. Responsible for meeting all team objectives.

• Generates documentation for production operations including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans.

• Maintains and generates new item information and routings per ERP requirements. Submits documents and create ECO's for any new and existing product and processes per Document Control guidelines.

• Develops and maintains budgets for multi-tasked projects.

• Conducts the financial analysis necessary to justify procurement of new capital equipment and supports the development of contractual agreements that incorporate supplier accountability for cost, schedule, and quality.

• Takes a proactive approach to the performance of job assignments with minimal input from supervision.

• Utilizes problem-solving skills for equipment troubleshooting, process debugging through data analysis, implementation of alternative manufacturing techniques and innovation that improves product and process efficiencies.

• Makes decisions at a level that can affect overall manufacturing efficiency, which may impact direct cost margins.

• Resolves complex technical problems independently.

• Carries out duties in compliance with established policies.

• Perform other work-related duties as assigned.

Required:

• BS degree in engineering discipline, preferably mechanical, Manufacturing or Industrial Engineering or equivalent combination of education and relevant work experience

• More than five (5) years of experience in a medical device or pharmaceutical environment

• More than three (3) years of managerial experience

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

• Experience in electrical-mechanical theory and application

• Skills in process and assembly automation

• Basic finance theory including experience with maintaining a budget

• 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, and basic quality tools.

Internal Partners:

Scientists, Production Managers, Marketing, Finance, Maintenance, Facilities, Planning and Materials departments

External Partners:

Vendors and Contractors

The work environment characteristics are representative of an office, laboratory and manufacturing environment.

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 $160,000 - $180,000 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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