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
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 role will be located onsite in Carlsbad, CA
The Responsibilities
- Integrity of Manufacturing Instructions (MI’s)
- Approve Manufacturing Routings and BOM’s, execute changes as required
- Equipment status, operating condition, and operating procedures (EIN’s)
- Workstation layout, equipment required, access to tools, storage of tools and equipment
- Material and process flow through the work areas
- Process improvement activities
- Process troubleshooting
- Capacity Analysis
- Cross-functional communication with individuals and departments that have a stake in the manufacturing operations
- Write validation protocols
- Write and Execute process and equipment validations
- Develop operator training protocols and assist in operator training
- Develop and Implement MFG documentation for new products and processes
- Communication with area manager, lead, supervisor, QE, and product improvement group
- Monitoring of equipment set-ups, documentation, and operating parameters
- Process yields and scrap
- New Equipment acquisition
- 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.
- 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
The Individual
Required
- BS degree in an engineering discipline or equivalent experience
- Two to five years’ experience.
- Proactive approach to the performance of job assignments with minimal input from supervision.
- Problem-solving skills include equipment troubleshooting process debugging through data analysis, implementation of alternate manufacturing techniques and innovation that improves product and process efficiencies.
- Decision making to a level that can affect overall manufacturing efficiency, which may impact direct cost margins.
- Must be able to resolve moderately complex technical problems independently and progressively gain the sills to solve complex problems with minimum supervision.
Preferred
- Mechanical, Manufacturing, or Industrial Engineering Degree
- Experience in a pharmaceutical or medical device environment.
- 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.
Key Working Relationships
Scientists, Production Managers, and Marketing Representatives, as well as the Finance, Maintenance, Facilities, Planning and Materials
The Work Environment
The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines.
The Physical Demands
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.
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 $79,000 - $105,000 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.
Equal Employment 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 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.
