Responsibilities and Duties

• Duties and responsibilities include, but are not limited to
• Manage the control of equipment design, qualification, and maintenance processes to fit cross-functional needs.  
• Create, develop, and improve equipment control procedures and processes.
• Build and manage a team to execute equipment controls, including: Equipment monitoring requirements; Preventive maintenance, calibration, repair; Equipment qualification; CER maintenance and monitoring
• Manage the support of equipment-related engineering objectives, including: Collaborating with Production and Engineering to drive continuous improvement initiatives; Drive the development of custom equipment, including definition, acceptance testing, and qualification; Qualification of duplicate equipment
• Identify and seek feedback from other functions to develop scalable and efficient equipment control solutions.
• Responsible for the investigation into causes of equipment failures and anomalies, and decisions regarding the mitigations. 
• Collaborate with Production to monitor equipment downtime.
• Responsible for implementing measures to reduce equipment downtime.
• Must execute work in a manner complaint with FDA and ISO regulations for medical device development and manufacture.
• Ensure the professional development of individual team members is planned and completed.
• Establish group and individual objectives, priorities, and metrics.
• Contribute to project planning and budgeting process.
• Must be a cooperative, engaged, hands-on leader.

Requirements

• Bachelor of Science in Engineering or related field preferred
• Must have 8+ years of experience in a regulated environment such as medical devices. 
• Minimum 3 years management experience.
• Proven track record of equipment development and implementation for volume production.
• Proven record of engineering leadership resulting in quantifiable improvements in quality, yield, cost, or process.
• Exhibit good problem solving and analytical skills. 
• Must have the ability to multi-task in a fast-paced environment and respond to changing priorities.
• Excellent communication and organization skills.