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, and integrating new products and analytical methods from R working with a cross-functional team, schedules and conducts audits, documents results, and develops and implements corrective actions Executes all tasks in accordance with QuidelOrtho's Quality System; carries out duties in compliance with established business policies The Individual Required: 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 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. 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 . #LI-HF1
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