Senior Operations Engineer

Job TitleLocation: Alachua, FLAnnual CIP bonus opportunity of up to $10,000Evergen 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; 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. Our comprehensive benefits package includes: Paid Time Off (PTO) 401(k) with company match Holiday pay Medical, dental, and vision insurance Short-term and long-term disability coverage Paid parental leave and much more!RESPONSIBILITIESResponsibilities involve validating equipment, understanding the interface and reactions of critical processes, installing and validating control systems, and starting, running, and upgrading the processesProvides manufacturing engineering support and recommendations for direct projects in assigned areasDefines and implements specific solutions to technical problems, completing the tasks associated with such projects and writing reports that clearly document the resultsLeads the development and improvement of the manufacturing process for existing and new productsSupports 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 deliverablesSupports or leads projects to incorporate capital equipment for new manufacturing lines and upgrades to existing linesLeads cross functional teams for projects and initiatives including lean manufacturing, cost savings, added capacity, and new product launchesOperates within the company's quality system to produce documentation for standard operating proceduresLeads continuous improvement efforts by performing time studies, value stream analysis, flow analysis and other lean related tasksMakes recommendations and implements changes in support of the whole operations team to achieve team goals in quality, cost, delivery, and safetyMay have direct or indirect oversight of other engineers or technicians including hiring, performance management, mentoring, professional development, etc.Other duties as assignedREQUIREMENTS:EducationBachelor's degree in an engineering discipline or a relevant field preferred.Experience6+ years of engineering experience in designing, modifying, and implementing processes and equipmentExperience working with Class III medical devices requiredExperience working within an ISO 13485 regulated environment requiredEducation requirements may be substituted for additional years of experienceSkillsMicrosoft Office Suite, advanced ExcelComputer Aided Drafting (CAD) softwareExcellent verbal and written communication skillsProject managementProblem-solving methodologiesTechnical writingStatistical methods and analysisLean Manufacturing PracticesTravelN/ASafety:Physical RequirementMove or lift objects up to 25 poundsFrequent (>75%) stationary position (standing or sitting) while utilizing digital displaysFrequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)Working EnvironmentOnsite: Office environment with assigned workstationRemote positions only: Home office environment with minimum distractionsMore about Evergen: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, manufacturing, and supply chain management.Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:Accountable: We own our actions and decisions.Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.Growth Mindset: We embrace challenges as opportunities for continuous learning.Customer-Centric: We prioritize customers at every touch point.Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions.

We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.