Senior 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.

At QuidelOrtho, we're advancing the power of diagnostics for a healthier future for all. Join our mission as our next Senior Manufacturing Engineer. This position provides 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 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.

• Maintain and improve manufacturing documentation including SOPs, work instructions, BOMs, and routings.

• Develops, maintains and approves manufacturing instructions, SPC, routings and BOM's and manufacturing documentation for new and existing products and processes.

• Monitor and improve key performance metrics such as yield, scrap, OEE, and throughput.

• Performs analysis, testing and qualification as required to support raw material and part configuration changes, and performs process improvement troubleshooting activities.

• 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 including conducting financial analysis.

• 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, generate equipment operating instructions and conducts operator and maintenance training.

• Applies engineering techniques to sustain and maximize current manufacturing efficiencies. Areas include: wet chemistry processing and filling, automated and manual assembly.

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

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

• Provides engineering guidance for cross-functional project teams.

• Lead cross-functional projects involving R&D, Quality, Operations, Supply Chain, and external partners.

• Support audits, CAPA investigations, NCR resolution, and change control (ECOs).

• Generates project plans and timelines

• Organizes and manages team meetings, generates agendas and writes meeting minutes.

• 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 and 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.

• Carries out duties in compliance with established policies.

• Performs other duties and projects assigned

Required:

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing or Industrial Engineering or 10 years of relevant work experience.

• A minimum of 5 years of experience in a pharmaceutical or medical device environment

• Understands GMP and lean manufacturing principles.

• Advanced problem solving skills

• Excellent verbal and written communication skills

• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience in electrical-mechanical theory and application, process and assembly automation, 2D & 3D CAD, hardware design, pneumatics, instrumentation, basic finance theory and basic quality tools

Internal Partners:

R&D, Production Managers, and Marketing, as well as the Finance, Maintenance, Facilities, Planning and Materials departments

Work environment is representative of manufacturing, laboratory and office settings.

Physical demands require the individual to lift loads up to 50lbs, work within restricted areas confined by equipment, and work within a low humidity environment with potential exposure to biological, toxic and corrosive reagents (50% of time). The individual is also required to work within the confinements of a cubical style office, and also within a laboratory setting (50%). Must be willing to work flexible hours.

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 $103,000 to $118,000 and is bonus eligible. 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 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 recruiting@quidelortho.com.

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