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Job #02636

About our client Our client is a rapidly growing medical device company headquartered in Gainesville, Florida that is focused on improving nerve repair and regeneration. The company has a rich pipeline of products to change the standard of care for patients with nerve damage. Position Location Process Engineer Gainesville, Florida Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Provide focused technical/engineering support to Operations on the manufacturing projects with an emphasis on capacity analysis, yield improvements, cost reduction and validations 2) Support continuous improvements of productivity, quality, cost, cycle time and yield of raw material 3) Analyze product/equipment specifications along with performance requirements to determine feasibility of new plant equipment or modifying the existing equipment 4) Assess continuously the efficiency and effectiveness of the manufacturing process 5) Support and collaborate with Research and Development as well as Quality Management on new product launches 6) Lead continuous improvement projects 7) Analyze and recommend capital equipment investments 8) Provide cross-functional project management support to other areas of the business 9) Act as a focal point for technical communications on quality issues 10) Utilize Root Cause Analysis Methods and statistical tools to resolve processing issues 11) Use statistical methods to determine the in-control/out-of-control processes 12) Participate in the development and execution of equipment installation and operational qualifications 13) Develop and implement methods and procedures for inspecting, testing and evaluating products for acceptability 14) Participate in the development and execution of process validations 15) Support integration of new business-work processes 16) Participate in developing and maintaining support systems for production work processes 17) Maintain calibration program 18) Engage in passionate debates around issues in a positive and constructive way with appropriate language and communicate truthfully, completely and directly with the person or people involved 19) Demonstrate consideration for others’ ideas and contributions 20) Anticipate and find ways to overcome obstacles to achieve goals 21) Look for ways to support all team members’ success 22) Involve team members appropriately in decision-making and information sharing Requirements 1) Bachelor’s degree in Mechanical, Chemical, Bio-medical or Industrial Engineering/related science with 3 years of experience 2) Medical device experience preferred (candidates with automotive, injection molding or extrusion manufacturing with strong validation experience will also be considered) 3) 3 – 5 years of experience in process engineering or process optimization and process development 4) Experience in cGMPs preferred 5) Strong validation experience 6) Lean Manufacturing experience preferred 7) Good problem-solving skills 8) Basic computer software skills, including, but not limited to MS Office, database, Excel and MS Project 9) Project management skills 10) Willingness to process and handle human and animal tissue 11) Other abilities – typing, standing, sitting, walking, pushing, pulling, stooping and seeing 12) Excellent communication (oral & written) skills 13) Passionate about work and results-driven 14) Ability to work as a team 15) Customer-centric approach 16) Demonstrated ability to respect others and show consideration 17) Willingness to travel – up to 50%