Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

As we continue to grow, we are seeking a Senior Process Engineer.

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.

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, leading / supporting troubleshooting investigations, implementing manufacturing process improvements, assessing feasibility of new manufacturing technology, ensuring manufacturing process robustness, revising/creating new documentation for Manufacturing, and validation of new or improved manufacturing processes and equipment.

This position in located in San Diego, CA

• Characterizes and optimizes manufacturing processes for yield, quality, and product performance

• 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.

• BS degree in an engineering discipline, preferably Electrical, Mechanical, Manufacturing, or Industrial Engineering, or equivalent experience.

• Minimum of 7 years related experience, preferably in a pharmaceutical or medical device environment. Preferred experience with custom automated assembly equipment.

• Must have experience in a GMP / FDA regulated environment; medical device production experience preferred

• Must be able to resolve complex technical problems independently and capable of progressively gaining the knowledge and skills to innovate and solve complex problems.

• Must have a thorough understanding of machine function, mechanical /electrical or software engineering.

• Must have demonstrated experience with the discipline of Design of Experiments

• Must have demonstrated experience with specification setting, capability analysis, measurement system analysis and Gage R&R

• Must have skills in statistical analysis

• Experience with Cognex In-sight Vision systems is highly desirable

• Experience with high throughput custom automation is highly desirable

EOE/AA Disability/Veteran