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Manufacturing Operations Engineer

2 months ago

Carlsbad, United States QuidelOrtho Full time
The Opportunity

QuidelOrtho combines the expertise of Quidel Corporation and Ortho Clinical Diagnostics, establishing a premier in vitro diagnostics organization renowned for its proficiency in immunoassay and molecular testing, clinical chemistry, and transfusion medicine.

With a workforce exceeding 6,000, we operate in over 130 countries, delivering prompt, precise, and reliable testing solutions wherever they are needed - from home to hospital, lab to clinic.

Our culture emphasizes the well-being of our team members, fostering actions that enhance happiness, inspiration, and engagement.

We are committed to forging meaningful connections, recognizing that employee satisfaction is intrinsically linked to business success.

Join us in our mission to harness the power of diagnostics for a healthier future for everyone.
The Role
As QuidelOrtho continues to expand, we are in search of a Manufacturing Engineer to join our Engineering Operations team.

The Manufacturing Engineer will provide engineering expertise in new product development, process enhancement, equipment management, manufacturing technologies, and project support to ensure the production of top-tier products.

This position will be based onsite.
Key Responsibilities

• Develop manufacturing strategies to facilitate the transition of products from R&D to production while ensuring product specifications align with standard raw materials and manufacturing processes.

• Create equipment specifications that define machine performance criteria, quantifiable through SPC and FEMA analysis.

• Formulate new equipment strategies and generate documentation to support the procurement of capital equipment.

• Develop manufacturing control plans and metrics to verify machine outputs comply with QSR standards.

• Oversee machine build activities through regular design reviews and milestones. Install and validate both existing and new equipment, generate operating instructions, and conduct training for operators and maintenance personnel.

• Utilize engineering techniques to sustain and enhance current manufacturing efficiencies.

Areas of Focus:
• Wet chemistry processing and filling
• Automated and manual assembly
• Identify and implement new technologies and continuous improvements to optimize manufacturing process output.

• Maintain Manufacturing Instructions, SPC, Routings, and Bill of Materials. Conduct analysis, testing, and qualification as necessary to support changes in raw materials and part configurations.

• Identify process control points and implement suitable process control parameters.

• Manage and/or provide engineering guidance for cross-functional project teams, either as a team leader or team member. Generate project plans and timelines using project management tools.

• Organize and manage team meetings, create agendas, and document meeting minutes.

• Ensure all team objectives are met.

• Generate documentation for production operations, including manufacturing and equipment instructions, validation protocols, design control, pFMEA, and control plans. Maintain and create new item information and routings per ERP requirements.

• Submit documents and create ECOs for new and existing products and processes according to Document Control guidelines.

• Perform duties in compliance with established policies.

• Undertake other work-related responsibilities as assigned.

The Individual
Required Qualifications:

• Bachelor's degree in an engineering discipline, preferably Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience.

• Two to five years of experience, ideally in a pharmaceutical or medical device setting.

• The Manufacturing Engineer must adopt a proactive approach to job assignments with minimal supervision.

• Strong problem-solving skills, including equipment troubleshooting, process debugging through data analysis, and the implementation of alternative manufacturing techniques that enhance product and process efficiencies.

This role requires decision-making capabilities that can influence overall manufacturing efficiency, potentially impacting direct cost margins.

Preferred Qualifications:
• 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 skills, and excellent written communication.

Key Working Relationships
Internal Partners:

• Engage in cross-functional tasks requiring interaction with members from all departments at various organizational levels.

• Primary customers include Scientists, Production Managers, and Marketing Representatives, as well as the Finance, Maintenance, Facilities, Planning, and Materials departments.

• Interaction 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 reflect a combination of office, laboratory, and manufacturing settings. Flexible work hours are necessary to meet project deadlines. The position requires the ability to lift up to 25 lbs and work within restricted areas confined by equipment.

• Up to 50% of the time may be spent in a low humidity environment with potential exposure to biological, toxic, and corrosive reagents; the remaining 50% may involve working in a cubicle-style office and laboratory setting.

• Walking, standing, and sitting for extended periods are routine tasks in this role. Specific vision abilities required include close and distance vision and the ability to adjust focus. Willingness to work 1st or 2nd shift is essential.

• The position requires the use of Personal Protective Equipment as specified.

• Minimal travel is required, including air and automobile travel, as well as overnight stays.

Salary Transparency

The salary range for this position considers various factors, including education, experience, knowledge, skills, geography, and candidate abilities, alongside internal equity and market data alignment.

At QuidelOrtho, it is uncommon for an individual to be hired at or near the top range for their role, and compensation decisions depend on the specific circumstances of each case.

The salary range for this position is $90,000 to $110,000.

QuidelOrtho provides 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 reserves the right to amend, terminate, or enhance the benefits provided as deemed appropriate.

Equal Opportunity

QuidelOrtho is committed to Equal Opportunity for all and ensures that all individuals, including those with disabilities, have the opportunity to apply for positions they are interested in and qualified 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 dedicated to providing reasonable accommodations to qualified individuals to enable them to perform their duties.