Senior Operations Engineer
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 Wlaffette, IN; Eden Prairie and Glencoe, MN; Neunkirchen, Germany; Glasgow, UK; and Marton, New Zealand. We are proud to be Great Place to Work® Certified in 2026, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.
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
- Responsibilities involve 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
Benefits
- Paid Time Off (PTO)
- 401(k) with up to a 6% company match
- Holiday pay
- Medical, dental, and vision insurance
- Short-term and long-term disability coverage
- Paid parental leave and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Senior
