Senior Manufacturing Engineer

RXinsider LTD.; Carlsbad, Northern (CA, KY); Hybrid; USD 105,000 - 115,000; Full time

Job summary

QuidelOrtho in Carlsbad, CA is seeking a Senior Manufacturing Engineer to drive transfer from R&D to production and optimize manufacturing processes. You will develop equipment strategies, maintain manufacturing instructions, and support capital equipment procurement while ensuring quality and compliance with GMP and lean principles.

The role is on-site, with collaboration across R&D, Production, Quality, and Planning teams, requiring strong problem-solving and communication skills.

Qualifications

• BS degree in an engineering discipline, preferably Mechanical, Manufacturing or Industrial.
• Minimum 5 years of experience in manufacturing operations.
• Understanding of GMP and lean manufacturing principles.

Responsibilities

• 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.

Skills

GMP knowledge

Lean manufacturing

Problem solving

Strong communication

Education

BS in Engineering (Mechanical/Manufacturing/Industrial)

Tools

2D CAD

3D CAD

Electrical-mechanical theory

Hardware design

Pneumatics

Instrumentation

Job description

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 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.

The Responsibilities

• 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.

The Individual

Required Skills

• 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.

Preferred Skills

• 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.
• Working in a regulated and high-speed manufacturing environment.

Internal

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

External

Vendors and Manufacturers

The Work Environment

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

The 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.

This position may require travel up to 10% of the time.

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 $105,000 - 115,000 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.

Equal 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 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 [e-mail].