Senior Manufacturing Engineer

The Opportunity

Quidel Ortho 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 Manufacturing Engineer 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 is an on site role 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.
• Maintains integrity of manufacturing instructions (MI’s).
• Develops, maintains and approves manufacturing instructions, SPC, routings and BOM’s and manufacturing documentation for new and existing products and processes.
• Processes yields and scrap.
• 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.
• Leads and organizes complex manufacturing projects.
• 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 additional work related duties as assigned.

• 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 manufacturing operations.
• 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.

• Experience in…