Job Summary In this role, you will be responsible for developing new technology and supporting existing technology to improve production, quality, profitability and safety.
This individual will be responsible for the planning, scheduling, execution of projects and communicating project status to targeted timelines.
This individual will also manage/assist in facility expansion/modifications.
Essential Duties and Responsibilities Support development of new technology, existing technology and existing production lines to improve quality, profitability and safety.
Develop, execute and document project assignments in compliance with committed timelines and project goals, and per established governance policies and procedures.
Ensure technical and customer requirements for assigned projects are achieved.
Develop and maintain required validation and project management documents.
Conduct or participate in routine project reviews with Project Teams and Management Perform design work, layouts, sketches, concepts, etc. as needed for projects and/or plant layouts.
Develop and/or review engineering change requests for modifications to processes, equipment and facilities.
Troubleshoot and repair of all automation.
Evaluate and maintain proper machine safeties to ensure employees are protected when operating any piece of automation.
Ensure automation lines are meeting their targeted output and OEE by analyzing production data.
Maintain quality finished product through proper maintenance and operation of all automation.
Provide timely notification to shift leaders and program managers of maintenance and down time issues.
Interfaces daily with engineering manager and shift support staff.
Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
Performs other duties as assigned by management.
Exhibits regular, reliable, punctual and predictable attendance.
Automation includes – assembly machines/fixtures, label applicators, robots, end of arms, separators and test equipment.
Any other equipment assigned by management.
Education Associate's Degree In a relevant Engineering subject required or Bachelor's Degree In a relevant Engineering subject preferred Work Experience Minimum 3 years Experience in medical device industry or other regulated industry required Minimum 3 years Experience in supporting technical project management preferred Preferred Knowledge, Skills and Abilities Background in medical devices/pharmaceutical would be a plus.
Knowledge of quality systems requirements, FDA Quality System Regulation, cGMP and relevant ISO standards Travel Requirements 5%: Up to 13 business days per year Physical Requirements Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
Additional Requirements Must be able to work a 40-hour work week, plus overtime and/or irregular hours as required to complete assignments.
May stand or sit for extended periods of time.
Must transport oneself to and from other areas of the facility and travel to other divisions when necessary.
Must have good visual acuity.
If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
Medical Device manufacturing requires strict adherence to standards.
Working environment is a manufacturing facility, which houses plastic injection molding machines.
Must tolerate fumes and particulate generated from various plastics.
Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
Must work constructively in an environment that may always be stressful due to competing resources while maintaining company confidentiality.