Operations Engineering Director / Sr. Director - Medical Device

Build and Lead a Newly Created Engineering Function Driving Evergen's Next Phase of Growth Location: on site at Headquarters in Alachua, FL (Preferred), Eden Prairie, MN, or West Lafayette, IN The Opportunity This is not a replacement role. As Evergen continues to grow as a global leader in regenerative medicine, we are creating a new executive leadership position responsible for building and leading our Global Operations Engineering organization. Historically, manufacturing engineering, process engineering, and packaging engineering capabilities have been managed independently within individual sites. As our business expands, we are taking the next step in creating a more connected, scalable, and technically advanced operating model. We are seeking an accomplished Director or Senior Director of Global Operations Engineering to lead engineering strategy across our U.S. manufacturing facilities while partnering closely with our operations team in Germany. This leader will establish the engineering capabilities, talent, systems, standards, automation, and technology roadmap required to support Evergen's future growth. Reporting directly to the Executive Vice President of Operations, this role will play a critical leadership role in shaping how products are transferred, scaled, manufactured, packaged, validated, and continuously improved across our global network. Why This Role Matters Growth Readiness Help build the engineering infrastructure, manufacturing capabilities, automation strategies, and technical expertise necessary to support Evergen's continued growth and global expansion. Organizational Alignment Create consistent engineering practices, standards, project governance, technology roadmaps, and manufacturing processes across multiple sites while leveraging local expertise. Strengthened Functional Excellence Develop world-class manufacturing, process, and packaging engineering capabilities that support innovation, operational excellence, quality, scalability, and customer success. Customer Impact Drive manufacturing reliability, process robustness, product quality, launch readiness, and operational efficiency to better serve customers developing life-changing medical technologies and regenerative medicine products. What You'll Lead This executive leadership role combines strategic vision with operational execution and will oversee: Global Process & Manufacturing EngineeringPackaging EngineeringCapital Projects & Engineering GovernanceTechnology Transfer & Design TransferProcess Validation & Equipment QualificationAutomation & Digital ManufacturingAI-Enabled Engineering SolutionsCapacity Planning & Manufacturing ScalabilityLean Manufacturing & Continuous ImprovementEngineering Talent Development & Succession PlanningMulti-Site Operational Excellence InitiativesCross-Functional Product Launch Support What Makes This Opportunity Unique Newly created executive leadership role with enterprise-wide impactOpportunity to build and shape a global engineering organization from the ground upDirect partnership with the EVP of Operations and executive leadership teamInfluence engineering strategy across multiple U.S. facilities and GermanyLead adoption of AI, automation, digital manufacturing, and emerging technologiesDrive large-scale capital investments and manufacturing modernization initiativesHelp define the future operating model of a rapidly growing regenerative medicine leaderJoin a Great Place to Work® Certified organization with a mission that improves patient outcomes worldwide Who Will Thrive in This Role The ideal candidate is an engineering leader, builder, and change agent who thrives on creating scalable systems and capabilities that drive business growth. You have successfully led manufacturing, process, or packaging engineering organizations within highly regulated medical device, biologics, pharmaceutical, or CDMO environments. You are equally comfortable discussing long-term technology strategy with executives and solving complex manufacturing challenges on the production floor. You bring the leadership presence to align multiple sites around a common vision while developing high-performing teams, modernizing engineering capabilities, and driving measurable business results. Education requirement Bachelor’s degree in Manufacturing, Mechanical, Biomedical, Chemical, Packaging, Industrial, or related Engineering disciplineMaster’s degree in Engineering, Business Administration, or a related field preferred Experience 12+ years of progressive experience in manufacturing, process, or packaging engineering within medical device, pharmaceutical, biologics, or another highly regulated manufacturing environment7+ years of people leadership experience, including responsibility for managers and geographically distributed technical teamsDemonstrated success leading multi-site engineering strategy, capital programs, process validation, design transfer, technology transfer, and cross-functional product launchesExperience operating effectively in a global, matrixed organization and collaborating across cultures, time zones, and functional reporting relationshipsExperience developing and implementing use cases in AI and Digital Automation Certification Lean certification, Project Management Professional certification, or equivalent operational excellence and project-delivery training preferred