Operations Engineering Director / Sr. Director - Medical Device

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Operations Engineering Director / Sr. Director - Medical Device

Full-Time Operations Alachua, FL, US

Salary Range: $200,000.00 To $240,000.00 Annually

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.

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 Engineering
• Capital Projects & Engineering Governance
• Process Validation & Equipment Qualification
• Automation & Digital Manufacturing
• AI-Enabled Engineering Solutions
• Capacity Planning & Manufacturing Scalability
• Lean Manufacturing & Continuous Improvement
• Multi-Site Operational Excellence Initiatives
• Cross-Functional Product Launch Support

What Makes This Opportunity Unique

• Newly created executive leadership role with enterprise-wide impact
• Opportunity to build and shape a global engineering organization from the ground up
• Direct partnership with the EVP of Operations and executive leadership team
• Influence engineering strategy across multiple U.S. facilities and Germany
• Lead adoption of AI, automation, digital manufacturing, and emerging technologies
• Drive large-scale capital investments and manufacturing modernization initiatives
• Help define the future operating model of a rapidly growing regenerative medicine leader
• Join 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 discipline
• Master’s degree in Engineering, Business Administration, or a related field preferred

Experience

Certification

Lean certification, Project Management Professional certification, or equivalent operational excellence and project-delivery training preferred