Automation & Controls Engineer

About the position

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Automation & Controls Engineer is responsible for the firmware, logic, code generation, documentation, backups, troubleshooting, and optimization of automated systems in use at the Product Development and GMP manufacturing areas of the Collagen Manufacturing Center (CMC). Inclusive in this role are WFI, CCA, PS, and other utilities as necessary. The incumbent applies Best Engineering Practices and sustainability initiatives to optimize Asset Life Cycle Management. The incumbent monitors performance and uptime of automated systems in support of supply chain integrity by keeping them in a state of continuous compliance and inspectional readiness. For project work, the incumbent translates the needs of stakeholders into automation code planning, execution, validation, and handover. The Senior Engineer, Automation, ensures that the execution of duties protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety.

Responsibilities

• Ensures that all team members receive training from Integra LifeSciences' Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, and awareness.
• Initiates and leads accident, near miss reviews and incident notifications.
• Ensures proper housekeeping procedures are maintained.
• Responsible for the team's compliance and meeting the quality standards as defined by Integra's SOPs, GMPs, Global Quality Standards, local and procedures, where applicable.
• Takes a holistic approach to Asset Life Cycle Management of automated systems inclusive of all parts and demands.
• Constantly monitors the performance of automated systems ensuring that performance and use sufficiently support the needs of Product Development and GMP manufacturing.
• Plays a key role in Technology Transfer ensuring that manufacturing specifications are well within critical utilities' validated states.
• Keeps backups of current code and archives past code.
• Maintains necessary equipment to interface with controllers to inspect or to download code, regardless of the controller age.
• Plays a leadership role in troubleshooting, repairs, and restorations.
• Translate the needs of multidisciplinary stakeholders into equipment selection to replace aging equipment or increase capacity.
• Coordinates work with the recipient departments.
• Assist in authoring SOPs for the use of automated systems.
• Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs, as required.

Requirements

• Bachelor's Degree in Engineering (preferred) or relevant technical science, or military experience equivalent.
• 5+ years in maintenance, installations and troubleshooting of automated systems.
• Knowledgeable in various off-the-shelf software applications and specialized applications for reading automation codes.
• Strong problem-solving and analytical skills.
• Ability to communicate effectively at all levels (both oral and written) both to in-house and external officials, where required.
• Medical device automated systems experience is preferred.
• Demonstrated ability to provide high-level customer service.