Operations Engineering Director / Sr. Director - Medical Device
About The Position
Evergen is creating a new executive leadership position to build and lead its Global Operations Engineering organization. The role will establish the engineering capabilities, talent, systems, standards, automation, and technology roadmap needed to support the company’s growth. It will lead engineering strategy across U.S. manufacturing facilities and partner closely with operations in Germany. Reporting directly to the Executive Vice President of Operations, the leader will shape how products are transferred, scaled, manufactured, packaged, validated, and continuously improved across the global network. The role combines strategic leadership with operational execution, including responsibility for process and manufacturing engineering, packaging engineering, capital projects, technology and design transfer, validation and equipment qualification, automation and digital manufacturing, AI-enabled engineering, capacity planning, lean manufacturing, talent development, multi-site operational excellence, and product launch support. The position is based onsite at headquarters in Alachua, Florida (preferred), or in Eden Prairie, Minnesota, or West Lafayette, Indiana. The successful candidate will build a global engineering organization, align sites around common standards and strategy, modernize manufacturing capabilities, and support quality, scalability, operational efficiency, and customer success in regenerative medicine.
Requirements
- Bachelor’s degree in Manufacturing, Mechanical, Biomedical, Chemical, Packaging, Industrial, or a related Engineering discipline.
- 12 or more years of progressive experience in manufacturing, process, or packaging engineering within medical device, pharmaceutical, or biologics environments.
- 7 or more years of people leadership experience, including responsibility for managers and geographically distributed technical teams.
- Demonstrated success leading multi-site engineering strategy, capital programs, process validation, design transfer, technology transfer, and cross-functional product launches.
- Experience operating effectively in a global, matrixed organization and collaborating across cultures, time zones, and functional reporting relationships.
- Experience developing and implementing use cases in AI and digital automation.
Nice To Haves
- Master’s degree in Engineering, Business Administration, or a related field.
- Lean certification, Project Management Professional certification, or equivalent operational excellence and project-delivery training.
- Experience in CDMO environments.
Responsibilities
- Build and lead Evergen’s Global Operations Engineering organization.
- Establish engineering capabilities, talent, systems, standards, project governance, and technology roadmaps to support business growth.
- Lead engineering strategy across U.S. manufacturing facilities and partner with operations in Germany.
- Oversee global process and manufacturing engineering and packaging engineering.
- Lead capital projects and engineering governance, including large-scale capital investment and manufacturing modernization initiatives.
- Oversee technology transfer, design transfer, process validation, and equipment qualification.
- Lead automation, digital manufacturing, and adoption of AI-enabled engineering solutions and emerging technologies.
- Guide capacity planning and manufacturing scalability.
- Drive lean manufacturing, continuous improvement, and multi-site operational excellence initiatives.
- Develop engineering talent and succession plans, including high-performing, geographically distributed teams.
- Support cross-functional product launches and improve launch readiness.
- Improve manufacturing reliability, process robustness, product quality, and operational efficiency.
- Create consistent engineering practices, standards, and manufacturing processes across sites while leveraging local expertise.
- Collaborate with executive leadership and cross-functional partners in a global, matrixed organization.
Benefits
- Opportunity to build and shape a global engineering organization from the ground up.
- Direct partnership with the EVP of Operations and executive leadership team.
- Enterprise-wide influence across multiple U.S. facilities and Germany.
- Opportunity to lead adoption of AI, automation, digital manufacturing, and emerging technologies and drive capital investment and manufacturing modernization.
- Great Place to Work® Certified organization.
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What This Job Offers
Job Type
Full-time
Career Level
Director
