Our client, medical device industry is seeking a Principal Engineer to join their team. As a Principal Engineer, you will be part of the regulatory and ngineering supporting regulatory team The ideal candidate will have musr Bachelor’s Degree is a MUST, especially if a candidate wants to be converted

Open to other regulated industries; medical device/pharma is preferred 7 -10 years Rockwell PLC experience Servo control systems (Rockwell, Yaskawa) which will align successfully in the organization.

Title: Principal Control Engineer

Location: Marion (North Cove), NC. ONSITE.

Duration: 6 months with the possibility of extension/conversion

Spotlight Call Notes:

Filling projects – bringing in new fill equipment for solution filling and overpouching for IV bags

Needs experienced Controls Engineers that can help with the projects

Controls are in Allen-Bradley (Rockwell hardware and software), legacy systems with upgrade projects

Main Skills

Experience in programming PLCs and HMIs in the Rockwell/Allen-Bradley platform (ControlLogix and MicroLogix, PanelView HMIs) is a MUST

Experience in troubleshooting

Experience with Vision Systems (Cognex)

Fanuc and Yaskawa robotics and some European (Staubli) robotics

Must Have Requirements

Bachelor’s Degree is a MUST, especially if a candidate wants to be converted

Open to other regulated industries; medical device/pharma is preferred

Solution filling is a “nice to have”

No lifting requirement but need to gown (bunny suit for Class III)

People leadership is not required but is preferred for Principal-level role

Position is for 6 months initially and a strong possibility of FTE conversion

Baxter is running a parallel DH search for this position

Team

3 main areas in Planned Process

Plastics (bags and components – tubing, injection sites, stoppers)

Filling (solution filling and overpouching)

Automated filling

Bags pouched further (overpouching)

Packing (bags in boxes which are labeled, sealed and packaged)

Interacting with Project Engineering group, Validation/Quality group and Manufacturing/Production group

Interview Process

1 – 2 virtual interviews with a potential in-person IV

Summary:

This position is responsible for providing day to day engineering support during weekdays and weekends (as required) to manufacturing areas. Due to the nature of this position, a very high degree of initiative, teamwork and communication are required. This position provides technical guidance to other engineering staff, engineering and maintenance technicians, maintenance supervisors, and others as required. The Principal Controls Engineer is tasked with providing analysis of plant manufacturing capacity, process optimization and automation, VIP identification and implementation, process validation planningexecution using lean manufacturing techniques and other problem-solving tools. Working knowledge of machine design, AutoCAD, and PLC Programming, troubleshooting and project management required.

Responsibilities:

• Develops or participates in the development of solutions to problems specific to assigned project.

• Participates in continuous improvement projects.

• Works with manufacturing and other functional groups on manufacturing regulatory compliance issues.

• Writes and/or executes, and reports on validation activities.

• Designs and performs routine testing, project experiments, analysis of data and reports results.

• Performs engineering studies on new equipment to determine proper settings, control points, etc. including data gathering during start up and test batches.

• Initiates new or revisions of protocols/operating instructions specific to the project.

• Performs NCR/CAPA investigations and tasks.

• Manage and execute change control activities related to equipment.

• Performs work assignments within production department that include training and technical support.

• Assists service department as an SME and leads equipment and/or process troubleshooting efforts as needed.

• Interprets, executes, and recommends modifications to operating policies where appropriate.

• Establish and control capital operating budgets for projects.

• Assist in the design, installation and start-up of new equipment and systems as required.

• Perform technical trouble shooting and implement problem resolution for existing and new equipment/systems.

• Coordinate with cross-functional teams (internal and external) on projects relating to existing and new product lines.

• Provide leadership, direction, and expertise for complex projects.

• Provide leadership and drive innovation within the plant.

• Performs other duties as assigned.

• The person in this position needs to frequently move between the office and the production floor.

• Must be able to work in a clean room environment without daylight / windows.

• Occasionally ascends/descends a ladder to access machinery.

What you will bring:

• Strong accountability and ownership.

• Strong leadership and project management skills.

• Knowledgeable in the practice and application of Lean Manufacturing.

• Knowledgeable in the practice and execution of validation protocols.

• Technical Software Skills Preferred:

• PLC: Allen-Bradley Control Logix, AB500, Safety PLCs

• HMI: Allen-Bradley

• Communication: Understanding of TCP/IP networks, RS-232 interfaces, Profibus communication, Fieldbus and HSSB

• Electrical: Hands on troubleshooting and diagnostic skills, understanding of Category 3 Safety Systems, E-Plan P8, AutoCAD, ability to read /draw schematics

• Familiarity with drives (such as servo and VFD) motion control, encoders, hydraulics, and pneumatics

• Robotics: Fanuc, Yaskawa

• Vision Systems: Cognex, Keyence

• Programming (Bonus): C#, C++, VB, SQL Server

Preferred Qualifications:

• BS in Engineering required (Electrical, Mechanical or Mechatronics Engineering preferred)

• 7 – 10 years’ experience in a similar role

• Experience in a regulated industry is a plus.

Technical skill (Software or other):

• 7 -10 years Rockwell PLC experience

• Servo control systems (Rockwell, Yaskawa)

• Ability to read and write electrical schematics.

• Hands on mechanical skill set is a plus.

• AutoCad drafting skills is a plus.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

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