Sr Manufacturing Engineer

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 Manufacturing Engineer is an integral member of the Assay Manufacturing Engineering team. This position will support a 24x7 high speed automated manufacturing operation and the associated engineering and maintenance functions when required to troubleshoot high level issues when impacting production. Additionally, the Manufacturing Engineer shall perform engineering studies and analyses on existing manufacturing processes to improve process reliability, product quality, and cost. This position is expected to be capable of carrying out an important segment of a large and complex engineering program or a smaller program of limited complexity and scope.

This position will be onsite at our Rochester, NY facility.

The Responsibilities

Conceives, plans, and implements solutions to technical problems requiring unconventional approaches, new designs, and equipment and process development; keeps abreast of new technical developments affecting the organization for an assigned area of responsibility; formulates strategies for the development of programs that bring new and improved engineering technology into the company; initiates, leads, and supports cost improvement projects and business continuity initiatives. Maintains clear communication with internal and external business partners regarding expectations, satisfaction, and / or quality of results.

Initiate and facilitate continuous improvement activities including larger scoped projects related to OEE and equipment obsolescence. Identifies new opportunities to increase equipment uptime and reduce business risk.

Assists in determining objectives and planning schedules of specific task within a given project / activity; apply comprehensive and diverse knowledge of engineering / business principles to a broad range of assignments. Coordinates and directs activities of other technical support staff and delegates their assignments as required.

Consults with maintenance to draft maintenance procedures for new designs, developing troubleshooting techniques, creation of preventative maintenance (PM) schedules, and providing recommended spare parts lists.

Supports the implementation of new equipment and / or the modifications to existing to improve plant efficiency and performance yields.

Carry out duties in compliance with all local, state, and federal regulatory bodies including FDA, EPA, OSHA, DEP and DEA.

Flexibility in work schedule along with off hours support and coverage as necessary.

PPE as required by work area

Maintains and ensures neat and orderly work areas.

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

The Individual

Required :

BS in Engineering (BSME, BSEE or BET is preferred) with 7 years minimum work experience or MS with up to 5 years' demonstrated experience in Engineering

Strong electrical & mechanical aptitude with troubleshooting experience

Adept with Microsoft Office tools (e.g. Word, Excel, Project, PowerPoint, etc.).

Ability to manage competing priorities in a results-driven environment

Familiar with CAD tools (e.g. AutoCAD).

Working knowledge and understanding of pneumatic systems and pneumatic logic

Executes the validation process, including conducting design reviews, pre-validation assessments, and installation, operational, and process qualifications

Preferred :

Experience with motor drive systems, process controls systems, automated manufacturing equipment and vision systems

Control Networking experience (Ethernet / IP, DeviceNet, ControlNet), and familiarity with databases

Experience working in an FDA Medical Device Manufacturing Facility with associated FDA and ISO regulations is preferred.

Key Interactions

Internal :

Operations, Maintenance, Facilities and Environmental Health & Safety, Quality and Regulator

External : Suppliers

Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.

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 $94,000 to $125,000 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.

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 .

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