Senior Operations Engineer

Evergen•Alachua, FL

9d•$75,000 - $95,000•Onsite

About The Position

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., Neunkirchen, DE., Glasgow, UK., and Marton, NZ. This role is responsible for validating equipment, understanding the interface and reactions of critical processes, installing and validating control systems, and starting, running, and upgrading processes. The position provides manufacturing engineering support and recommendations for direct projects in assigned areas, defines and implements specific solutions to technical problems, and leads the development and improvement of the manufacturing process for existing and new products. It also supports or leads the initiation, investigation, and closure of non-conformances and CAPA, and executes project management leadership for multiple projects. The role supports or leads projects to incorporate capital equipment for new manufacturing lines and upgrades to existing lines, and leads cross-functional teams for projects and initiatives including lean manufacturing, cost savings, added capacity, and new product launches. The Senior Operations Engineer operates within the company’s quality system to produce documentation for standard operating procedures and leads continuous improvement efforts by performing time studies, value stream analysis, flow analysis, and other lean related tasks. They make recommendations and implement changes in support of the whole operations team to achieve team goals in quality, cost, delivery, and safety. This role may have direct or indirect oversight of other engineers or technicians, including hiring, performance management, mentoring, and professional development.

Requirements

Bachelor’s degree in an engineering discipline or a relevant field preferred.
6+ years of engineering experience in designing, modifying, and implementing processes and equipment
Experience working with Class III medical devices required
Experience working within an ISO 13485 regulated environment required
Education requirements may be substituted for additional years of experience
Microsoft Office Suite, advanced Excel
Computer Aided Drafting (CAD) software
Excellent verbal and written communication skills
Project management
Problem-solving methodologies
Technical writing
Statistical methods and analysis
Lean Manufacturing Practices

Responsibilities

Validating equipment, understanding the interface and reactions of critical processes, installing and validating control systems, and starting, running, and upgrading the processes
Provides manufacturing engineering support and recommendations for direct projects in assigned areas
Defines and implements specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the results
Leads the development and improvement of the manufacturing process for existing and new products
Supports or leads initiation, investigation, and closure of non-conformances and corrective and action preventative actions (CAPA)
Executes project management leadership for multiple projects including leading core team meetings, outlining timetables, reporting out to management, and being accountable for deliverables
Supports or leads projects to incorporate capital equipment for new manufacturing lines and upgrades to existing lines
Leads cross functional teams for projects and initiatives including lean manufacturing, cost savings, added capacity, and new product launches
Operates within the company’s quality system to produce documentation for standard operating procedures
Leads continuous improvement efforts by performing time studies, value stream analysis, flow analysis and other lean related tasks
Makes recommendations and implements changes in support of the whole operations team to achieve team goals in quality, cost, delivery, and safety
May have direct or indirect oversight of other engineers or technicians including hiring, performance management, mentoring, professional development, etc.
Other duties as assigned