Senior Manager, Manufacturing Engineering at QuidelOrtho

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

As the company continues to grow, as one QuidelOrtho we are seeking a Senior Manager of Manufacturing Engineering. The Senior Manager of Manufacturing Engineering will lead a team of engineers and technical professionals to drive world-class manufacturing performance in a high-speed medical device production environment. This role is responsible for improving Overall Equipment Effectiveness (OEE), implementing automation solutions, and leading continuous improvement initiatives that enhance productivity, quality, and cost efficiency while ensuring compliance with FDA, ISO 13485, and GMP regulations.

This position is in Rochester, NY.

Schedule: Primary A shift, Monday - Friday; however, may require extended hours or weekend work to support the 24/7 operations or project deliverables.

The Responsibilities

• Lead and develop a team of manufacturing and automation engineers to optimize production performance and reliability.

• Build a culture of accountability, innovation, and continuous learning within the engineering team.

• Mentor engineers in technical and leadership competencies.

• Promote collaboration between engineering, maintenance, and production teams.

• Develop and execute engineering strategies focused on OEE improvement, lean manufacturing, and process automation.

• Partner with Operations, Quality, and Maintenance to ensure manufacturing systems are robust, validated, and scalable.

• Define engineering roadmaps for automation, process optimization, and new technology adoption.

• Lead structured problem-solving (DMAIC, 8D, A3) to eliminate process inefficiencies and waste.

• Drive Kaizen, SMED, 5S, and other lean initiatives to increase uptime and reduce cycle times.

• Ensure processes and equipment meet FDA and ISO 13485 requirements.

The Individual

Required:

• Bachelor's degree in Mechanical, Manufacturing, Industrial, or Electrical Engineering (Master's preferred).

• 10+ years of experience in manufacturing engineering, with at least 5 years in a leadership role.

• Strong leadership, communication, and cross-functional collaboration abilities.

• Strong background in continuous improvement and structured problem solving.

• Strong background in automation technologies ((PLCs, robotics, motion control, vision systems, and HMI/SCADA)

• Working knowledge of FDA, ISO 13485, and GMP requirements.

• Required Travel Less than 5%

Preferred:

• Proficiency with data analysis, SPC, and manufacturing performance tools (Power BI, Ignition, or similar).

Key Working Relationships

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

External Partners: Suppliers, Service Providers

Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time you will be, standing, walking or sitting for extended periods of time. Ability to lift up to 50 lbs. Flexible work hours to meet project deadlines.

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 $128,000.00 to $218,000.00 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 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 [email protected].

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