Senior Manufacturing Engineer

QuidelOrtho CorporationRochester, NY
37d$94,000 - $125,000Onsite

About The Position

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.

Requirements

  • 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

Nice To Haves

  • 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.

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

Benefits

  • 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.
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