Manufacturing Engineer

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.

As we continue to grow as QuidelOrtho, we are seeking a Manufacturing Engineer for the Fluids Manufacturing facility. The Manufacturing Engineer will be deployed to assist operations in the improvement of operational process capabilities, yield improvements, scrap reductions, and in the use and execution of the site's usage of SAP processes, systems, and set-ups for both operations and materials management organizations. In addition, will provide expertise in determining process capabilities, variation analysis and analytics, and in the reduction of process variations leading to improved first time quality performances, reduced scrap, and improved lot to lot process variations. This position will provide oversight and assistance in the introduction of SPC process controls, training of personnel in their use, and in the development of improved operator skill sets in variation reduction and process performance improvements. The individual will partner with engineering and maintenance teams to support operations initiatives for improved OEE machine performances, scrap reductions, and improved process performances. This individual will know how to apply lean techniques, utilize the QIC initiatives, and in the usage and implementation of several varied problem solving tools, techniques, and methodologies. The role will involve collaboration with both external component suppliers, external manufacturing sites and internal manufacturing sites to assist with development of process specifications on new product introductions.

This position is in Rochester, NY.

• Develop process capability analysis and variation reduction strategies to solicit improved process performances, reduced scrap events, and improved process yields.

• Support operations in further integration of SAP processes and utilization efforts. Expand the use of SAP through execution of problem solving and improvement initiatives to achieve reduced material usages and variances associated with work order management processes, including the WO closing and variance accounting resolution activities. These activities will include support of inventory management processes, transactions, and the accuracy of transactional events leading to improved inventory management practices.

• Develop and execute formal problem- solving activities through the use of the QIC techniques and other lean methodologies to improve throughput, reduced lead-time, and increase OEE performances of the sites manufacturing assets and processes.

• Support new product introductions through specification development and process capability requirements to assure new product introductions are validated with optimal process capabilities, yields, and process specification limits that represent true and sustainable manufacturing process performance, and improved field performances.

• Provide guidance and support of safety initiatives, practices, equipment guarding, and equipment LOTO processes.

• Provide a technical resource to manufacturing as it relates to operator training, process consistency, the elimination of the 8 wastes, and in the use of various lean tools and methodologies.

• Perform other work related duties as assigned.

Required:

• Associates Degree with 5-10 years experience, or engineering degree with 3-5 years of experience in mechanical engineering or an equivalent technical degree.

• Electromechanical device process development engineering skill set.

• Strong communication (both written and verbal) as well as influencing skills as interaction with multiple functions and various suppliers.

• Proficient in reading and interpreting GD&T, tolerance analysis.

• Assist engineers in implementing process/design changes.

• Lead by example when completing daily work.

• Work within the team dynamic to promote Win-Win solutions to problems.

• Ownership and accountability to project results is clearly demonstrated.

Preferred:

• A broad-based knowledge of assembly and component manufacturing processes within the Diagnostics and/or Medical Device Industry.

• Demonstrated ability to lead, under minimal oversight, elements of complex technical projects confidently.

• Experience in an FDA regulated and/or GMP environment.

• Experience in process improvement efforts using Process Excellence, Six Sigma and Lean Tools.

• Proficiency with Microsoft Office is required. Knowledge of Product Data Management tools (PDM).

Internal: Operations, Maintenance, Facilities and Environmental Health & Safety, Quality and Regulatory

External: Suppliers

The work environment characteristics are representative of an office environment. Up to 75% of time at desk, standing or sitting extended periods of time. No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required.10% travel overall (including International) but could require up to 50% travel for short durations during commissioning of new equipment at suppliers.

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 that facts and circumstances of each case. Salary range for this position is $80,000 to $136,000 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.

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.

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