Senior Process Engineer

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 Process Engineer provides engineering expertise in the areas of process development and improvement, equipment and sustaining engineering, manufacturing technologies, and project support to assure the production of world-class products. They are required to use structured problem-solving and acquired scientific/engineering knowledge to improve product quality and delivery and to resolve manufacturing issues. They will be responsible for selecting the processes to be used, determining orders of operation, and ensuring that all special equipment required to manufacture QuidelOrtho products are available for use. Individuals will provide direction and support to Chemistry Manufacturing, Product Development, Engineering, and Operations to ensure production processes are robust.

This is a hands-on position whose key activities include (but are not limited to):

• Mapping of product performance to process parameters
• Reduction/control of variation
• Yield improvement
• Ensuring manufacturing process robustness
• Control/mitigation of process drift
• Leading/supporting troubleshooting investigations
• Conducting Corrective and Preventative Actions
• Implementing process improvements
• Assessing feasibility of new manufacturing technology
• Revising / creating new documentation for Manufacturing (manufacturing work instructions, routings, bills of material, SOPs, etc)
• Validation of new or improved manufacturing processes
• Integrating new products and analytical methods from R&D into Operations

This Position will be located onsite in Carlsbad.

Responsibilities

• Characterize, optimize, validate and ECO manufacturing processes to improve efficiency, yield, quality and robustness of current processes
• Leads teams in troubleshooting and problem-solving efforts related to product performance
• Design and develop processes to reduce variability within the product, improve operating capabilities, and help ensure safety
• Champions new technologies and influences department strategy in improving product quality, production, safety, efficiency, and costs
• Understands the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility
• Maintains records and reporting systems for coordination of manufacturing operations
• Estimates manufacturing cost, return on investment analysis of capital equipment, determines time standards, and makes recommendations for tooling and process requirements of new or existing product lines, works with external suppliers to develop custom capital equipment for the manufacture of product
• Builds strong working relationships across functional areas
• Onboards, qualifies, and validates new equipment in accordance with all applicable facility and quality procedures
• Drives 5S Lean Activities by developing, implementing, and maintaining methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub-assemblies and final assemblies
• Demonstrates commitment to the development, implementation, and effectiveness of the QuidelOrtho Quality Management System in accordance with regulatory agencies
• Leads evaluation of non-conformances, CPAR, failure investigations, and deviation requests arising from the Chemistry and Device Manufacturing areas
• Represents Process Engineering in assigned R&D and Project Team meetings for technology transfers, and provide technical expertise and support for analytical method development, validation and process scale-up, and current production capabilities in manufacturing
• Leads the audit of manufacturing processes; working with a cross-functional team, schedules and conducts audits, documents results, and develops and implements corrective actions
• Executes all tasks in accordance with QuidelOrthos Quality System; carries out duties in compliance with established business policies

Individual Requirements

• BS degree in an engineering discipline, preferably Electrical, Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience
• Minimum of 8 years related experience, preferably in a pharmaceutical or medical device environment
• Preferred experience with custom automated assembly equipment
• Experience in a GMP / FDA regulated environment; medical device production experience preferred
• Ability to resolve complex technical problems independently and capable of progressively gaining the knowledge and skills to innovate and solve complex problems
• Thorough understanding of machine function, mechanical /electrical or software engineering
• Demonstrated experience with the discipline of Design of Experiments
• Demonstrated experience with specification setting, capability analysis, measurement system analysis and Gage R&R
• Skills in statistical analysis
• Knowledge and ability to use MS Office and other manufacturing systems. Typical computer applications include Solid Works, AutoCAD, MS Word, Excel and Project. May include Lab View, PLC and other specialty machine and vision SW, statistical analysis, vision inspection, and programming and motion control software
• Must be organized, detail oriented, and have strong verbal and written communication skills
• Must take a proactive approach to the performance of job assignments with minimal input from supervision
• Required problem-solving skills include equipment troubleshooting, process debugging through data analysis, implementation of alternate manufacturing techniques, and innovation that improves product and process efficiencies
• This position requires decision making to a level that can affect overall manufacturing efficiency, which may impact direct cost margins
• Must have experience with validations, technical writing, Six Sigma, SS, OEE and DOE
• Knowledge of mechanical design, materials, mechanical, pneumatic and electrical systems, tolerance analysis, laser printing, ultrasonic welding, infrared laser welding, micro-fluidic dispensing or plastic injection molding is desirable
• Strong analytical and problem-solving skills
• Good knowledge of process optimization, scale up and standardization
• Good organizational skills, and the ability to manage multiple tasks
• Ability to plan and execute experiments to:
• Develop new processes and set specifications
• Characterize materials and set specifications
• Troubleshoot problems
• Write and execute associated validations
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Strong knowledge of relevant analytical tools (Design of Experiments, Statistical Process Control, Problem Solving, etc.)
• Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills
• Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts)
• Knowledge of related quality system regulations and processes
• Appropriate computer skills (e-mail, word processing, graphing software)

Key Working Relationships

• Internal Partners: Product Line Engineers, Software Controls Engineers, Materials Engineers, Manufacturing Engineering Technicians, Process Chemists, QC Analysts, Manufacturing Operators, Quality and Regulatory
• External Partners: Materials and equipment suppliers

Work Environment

• The work environments include manufacturing, laboratory, and office areas, and may include handling of potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues and samples
• Flexible work hours to meet project deadlines
• All activities must be executed in compliance with QuidelOrtho Safety Policy
• 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
• Must be willing to work 1st or 2nd shift
• Position requires use of Personal Protective Equipment as posted
• Up to 75% of time on the manufacturing floor, at lab bench or desk; walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role
• Must have the ability to operate manufacturing and lab equipment

Physical Demands

• Position requires ability to lift up to 30 lbs., work within restricted areas confined by equipment
• Up to 50% corrosive reagents; and up to 50% is required to work within the confinements of a cubicle style office, and also within a laboratory setting
• Walking, standing and sitting for long 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
• Up to 75% of time on the manufacturing floor, at lab bench or desk; walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role
• Must have the ability to operate manufacturing and lab equipment

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 $102,360.25 - $130,000 USD Annual annually

Benefits

• 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