The Senior Process Engineer will be responsible for designs, developing, testing, and evaluating manufacturing systems (assembly and packaging operations) during conceptual and pilot development and the introduction of new programs into production.
•____________________________________________________________________ Plans, schedules, conducts, and coordinates assigned engineering work; monitors work for compliance to applicable codes, standards (i.e. FDA, ISO, OSHA) and accepted engineering practices.
•______________________________________________________________ Coordinates the launch of new product designs and enhancements to existing product designs to ensure smooth transition to full production.
•________________________________________________________________ Interfaces with the Development, Quality, Manufacturing, Supply Chain functions as well as suppliers to conduct problem solving activities.
•__________________________________________________________________ Assures smooth implementation of new and revised product and process designs into production.
•_________________________________________________________________ Performs design reviews and pre-validation assessments to ensure a smooth startup of new processes.
•_________________________________________________________________ Performs analytical problem solving and utilizes structured decision making skills.
•__________________________________________________________________ Confers with management, and other staff regarding manufacturing capabilities, production schedules, and other considerations to ensure smooth transition of new or enhanced product and/or processes to full production.
•_______________________________________________________________ Participates in or lead problem solving team projects.
•_________________________________________________________________ Conducts moderately complex projects where analysis of situation requires a thorough and robust knowledge of various identifiable engineering methods and factors.
•_________________________________________________________________ Provides guidance to engineering technicians on assigned tasks and projects.
•___________________________________________________________________ Guides the successful completion of projects and may function in a project leadership role.
•_________________________________________________________________ Develops operating procedures and/or work instructions to ensure adequate manufacturing practices per FDA requirements.
•________________________________________________________________ Maintains safe and clean working environment by enforcing procedures, rules and regulations.
Description of Work Environment: Clean air conditioned
· BS and 7+ years’ relevant experience in Engineering (preferably Mechanical or Biomedical).
· Must be able to communicate appropriately and accurately both orally and in writing the progress of assignments and product development efforts.
· Must be able to complete effective Validations with a moderate to complex scope.
· Must have practical experience and solid understanding of mechanical design principles, testing and manufacturing processes.
· Experience in project management and leading small teams.
· Ability to handle multiple tasks concurrently.
Independent thinker and problem solver.