Our client, a Leading medical device manufacturer, expanding and growing, is seeking an Automation Sustaining Engineer who will be taking equipment developed by automation integrators and moving it into Manufacturing Operations. The automation engineer will need to be skilled in use of robotics, vision, sensors, PLCs and integration of equipment technologies. The automation engineer should have experience operating and testing automation, writing Factory Acceptance Tests (FATs) and Validation protocols in an FDA or regulated environment. This is not an automation equipment design position, it is commissioning and sustaining position.
As the automation engineer, you will provide Operations engineering support for commissioning moderate to complex equipment in manufacturing clean room environments. Responsibilities include writing buyoff, validation, operating, training and testing documents for equipment commissioning in GMP environment and then executing the protocols. So, you should have some sustaining manufacturing Automation experience as well as experience on managing new automation commissioning. Engineering and Operations activities may include planning, developing, writing protocols, designing, troubleshooting, installation and/or any other aspect of Engineering or Operations work.
Automation Engineer Responsibilities:
- Plan, design, develop and execute operating and validation protocols to perform factory buyoffs of moderate to complex automation and execute installation and operation qualifications.
- Develop, implement and support changes, perform re-qualifications of Automated machines and procedures.
- Designs, improves and implements production equipment/processes, fixtures/jigs for production equipment and assembly to improve product quality, increase productivity or reduce costs. Hands on investigation and troubleshoot manufacturing issues. Perform Engineering Studies to maintain equipment in prime operational control.
- Develop validation IQ/OQ/PQ protocols, test protocols. Execute protocols and write reports to ensure equipment/processes meet part/assembly specifications and regulatory requirements.
- Provide training and coaching to engineers and technicians on new and existing equipment and procedures.
- Project engineering using Microsoft Project, statistical programs and Microsoft Office as well as 3D CAD or Solidworks software.
- Collaborates and communicates with company interdepartmental groups including Regulatory, Quality Assurance, R&D and Process Engineering.
- Demonstrated use of analytical tools and procedures used in Lean Six Sigma such as utilizing the DMAIC methodology for continuous improvement.
- Perform Mechanical tooling and fixture design for equipment improvements.
- Will use working knowledge of GMP standards and procedures
Automation Engineer Requirements:
- B.S. Degree in engineering field. Electrical Engineering is preferred
- Requires a Bachelor’s degree in a technical discipline, and a minimum of 5-8 years related experience or Master’s degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
- 7 to 10 years related experience in a regulated manufacturing environment (medical device preferred).
- Minimum of 5 years project and/or people management experience.
- Experience in working in clean room environments and/or GMP standards and procedures.
- Demonstrated experience in medical device automation, test methods/standards, processes and related equipment.
- Working knowledge of equipment validation (URS, FAT, SAT, IQ, OQ & PQ)
- Excellent documentation skills
- Ability to flex work hours to support on all operational shifts when required.
- Ability to travel to other sites, vendors and / or customers both domestically and internationally (<10% travel).
Automation Engineer Skills preferred:
- Demonstrated project engineering on the commissioning of Automated systems on the factory floor.
- Working knowledge of using machine vision for inspection.
- Working knowledge of PLC and HMI code
- Use Solidworks to create models and drawings for equipment designs.
- Strong mechanical equipment development background
- Excellent communication (written and verbal) and personal interaction skills.
- Proven ability to work hands-on in a fast-paced environment.
- Proven ability to multi-task, prioritize projects, and maintain timelines.
- Flexibility in a changing environment.
- Detail oriented and organized.
- Semi-Automation or automation experience is preferred.
- Excellent skills in verbal and written communication, ingenuity and creativity, interpersonal and management.
- Strong influencing, motivating and conflict resolution abilities. Demonstrated experience managing multiple projects of significant size and scope.
- Knowledge of GMP. GLP, FDA, ISO and sterilization quality system standards.
- Strong and diverse materials, manufacturing, quality, automation and product design skills. Experienced with multiple manufacturing and assembly methods.
- Demonstrated reliable communication, teamwork and organizational skills.
- Ability to quote manufacturing costs and cost-justify tools / equipment.
- Ability to develop and meet project schedules, along with contingency plans.
- Experience in authoring, reviewing and approving validation protocols, reports and other technical documentation.
- Excellent attention to detail and accuracy. Establishes and maintains high standards for quality and considers excellence a fundamental priority.
- Executes, as appropriate, engineering and quality methods including FEA, Tolerance Analysis, DOE, SPC, FMEA, Process Capability, Root-Cause Analysis, etc.
- Proficiency with MS Office Suite, Microsoft Project, flow charting, Minitab, AutoCAD and SolidWorks.
- Capable of embracing innovation and providing creative solutions
- Flexible and adaptive to changing priorities. Able to work effectively under time-sensitive conditions.
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