Operations Engineering Director / Sr. Director - Medical Device

Evergen; Eden Prairie, West Lafayette (MN, IN); On-site; USD 200,000 - 240,000; Full time

Job summary

Evergen is seeking an experienced Operations Engineering Director / Sr. Director to build and lead a global Operations Engineering organization for medical devices. This on-site role will drive strategy across U.S.

manufacturing facilities and collaborate with our Germany team to standardize processes, automation, and technology roadmaps. You will oversee capital projects, process validation, automation, and digital manufacturing, guiding multi-site manufacturing excellence and product launch

Qualifications

• Experience leading manufacturing, process, or packaging engineering in regulated medical device environments.
• Proven ability to develop and execute an enterprise-wide engineering strategy.
• Strong cross-site leadership across multiple sites and geographies.
• Bachelor’s degree in Engineering; MBA or Master’s preferred.

Responsibilities

• Lead Global Operations Engineering strategy across U.S. facilities and partner with German operations.
• Oversee capital projects, governance, and qualification programs.
• Drive automation, digital manufacturing adoption, and AI-enabled solutions.
• Champion lean and continuous improvement across sites.

Skills

Global leadership

Leadership

Manufacturing engineering

Automation & digital manufacturing

Regulated medical devices

Strategic planning

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Operations Engineering Director / Sr. Director - Medical Device

Full-Time Operations Alachua, FL, US

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

Location: on site at Headquarters in Alachua, FL (Preferred), Eden Prairie, MN, or West Lafayette, IN

Build and Lead a Newly Created Engineering Function Driving Evergen's Next Phase of Growth

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