Senior Operations Engineer

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Full-Time Alachua, FL, US

Salary Range: $ To $ Annually

Alachua, FL

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, 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.

• 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
• 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

• 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

• N/A

• 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

• N/A

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Onsite:
  Office environment with assigned workstation
• Remote positions only:
  Home office environment with minimum distractions

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation,…