Senior Manager Manufacturing Engineering

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 6000 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 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 will be onsite in our Rochester NY.

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.

• Perform other work-related duties as assigned

The Individual

Required:

• Bachelors degree in Mechanical Manufacturing Industrial or Electrical Engineering (Masters 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 Interactions

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

External: Suppliers Service Providers

Work Environment

The work environment characteristics are representative of a manufacturing laboratory or warehouse environment. Computer use. Sounds or a pitch that may cause distraction. Exposures to chemistry and airborne particles. Working around moving machinery.

Physical Demands

Position requires 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. 10% travel overall (including International) but could require up to 50% travel for short durations during commissioning of new equipment at suppliers

Salary Transparency

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 $128000 to $218000 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 .

#LI-SP1