Operations Director - Medical Device/CDMO

Location :

On site at 6455 City West Pkwy Suite 100, Eden Prairie, MN 55344

Bonus :

Eligible for $40,000 annually RTI Surgical is now Evergen! This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN. and Collagen Solutions, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale. Evergen 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, DE., Glasgow, UK., and Marton, NZ. Read more about this change and Evergen s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;

RESPONSIBILITIES

o Oversees manufacturing, purchasing, engineering, warehouse, and distribution activities in the facility o Ensures that the plant achieves key performance goals of Safety, Quality, Delivery, Cost, Inventory, and People o Supports the total revenue goals of the business, ensuring alignment with key commercial and marketing leaders o Drives projects using the techniques of lean manufacturing, six sigma, and employee engagement, resulting in a culture of continuous improvement o Directs capital equipment requirements including efficient use of equipment, materials, and personnel required to produce implants o Facilitates high employee engagement at all levels to ensure the best performance from the organization o Manages production operations while developing methods to maximize efficiency, minimize cost, and achieve operating budget objectives o Implements a continuous improvement safety culture that drives the organization to achieve the goal of zero incidents o Ensures that all operations comply with all federal, state, and local environmental expectations o Implements operational strategies and action plans to ensure that the facility supports the company s strategic initiatives

REQUIREMENTS

Education Bachelor s degree in business, engineering, or related field, Master s Degree preferred Experience 10+ years of experience in a regulated processing or manufacturing facility 7+ years of leadership experience 4+ years of medical device industry experience Skills Excellent verbal and written communication Microsoft Office Suite Enterprise Resource Planning (ERP) software Budget Management Project Management Process Improvement Methodologies Strategic Planning Knowledge of MS project software, Outlook, MS Excel, MS Word, MS PowerPoint. Travel 25% Physical Requirement Move or lift objects up to 50 pounds Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays Frequent (>75% fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Working Environment Onsite:

Office environment with assigned workstation

COMPANY SUMMARY

Evergen 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 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 headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., and Neunkirchen, Germany. 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.