Staff 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.

As we continue to grow as one QuidelOrtho, we are seeking a Manufacturing Engineer IV, responsible for supporting new/existing equipment and processes located at the Raritan, NJ site. This position will be responsible for applying extensive and diversified knowledge of electronic principles and practices in a broad range of assignments and related fields. Makes decisions regarding engineering problems and methods and represents the company in conferences to solve problems and to plan and coordinate work. Responsible for the engineering and quality assurance of part of a major project or for a complete small project.

This position is onsite in Raritan, NJ.

The Responsibilities

• Design and selection of new facility and production systems, modifications and upgrades to existing equipment, preparation of capital estimates, generation of capital funding, control of project budgets, timely execution of new installations, equipment commissioning and validation, development and periodic review of standard operating procedures and specifications, maintenance specifications, documentation revision control, and project scheduling and coordination to meet all performance requirements including cost, quality, maintenance, safety and environmental criteria. 

• Work in direct support of the Raritan business operating units to support equipment design and purchases, upgrades, and process improvements. Responsibilities will include developing, coordinating, documenting, and delivering equipment and upgrades with the associated regulatory and change management actions related to projects. 

• Provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and identifying and correcting technical issues for all production shifts, as required.

• Manage contractors, provide maintenance staff direction on projects, and coach subordinate engineers.

• cGMP responsibilities will include owning and managing quality events related to process, manufacturing facility equipment issues, corrective/preventive actions, and equipment /process validations.

• Provide technical support and interact with regulatory agencies during site audits.

• Must possess strong electrical knowledge and ability to decipher PLC code for troubleshooting

The Individual

• Minimum requirement of a Bachelor’s degree in Electrical Engineering and (7- 10) years of medical device and/or pharmaceutical manufacturing process and associated project management experience. Advanced degree preferred. 

• Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems. 

• Demonstrated skills in development, writing, and executing cGMP-based process and equipment validations.  

• System design knowledge specifically in the following areas is required: Building Automation Systems, PLC programming, vision systems, labeling equipment, servo motors, motion control and automated filling, packaging and assembly equipment. 

• Demonstrated written and verbal communications skills in formulating and communicating technical objectives into viable capital projects as well as interpreting and communicating technical content related to system design, function, and performance to management and auditing agencies. 

• Knowledge of FDA and other regulatory guidance is required (inclusive of participation in commissioning, qualification and validation activities). 

• The candidate is required to be proficient in Microsoft MS Office (Word, Excel, Project, Outlook and PowerPoint), and AutoCAD. 

• Possess the knowledge of Six Sigma methodology for this role. 

• Display a sense of urgency.

• Share and train on technical information with individuals / groups.

• Skilled in good documentation practices (cGMP & Maintenance documentation)

• Available to work on other shifts, if required.

• Must be able to work independently with minimum supervision, be detail oriented, self-motivated/proactive and work well/interact with other individuals/groups.

• Must have Ariba purchasing system experience in purchase, receipt, and reconciliation of purchases..

• The position will require 5-10% travel and will be located at Raritan, NJ.

• This position is not currently eligible for visa sponsorship.