Operations Director

Industry: Life Sciences / Advanced Manufacturing

Location: Greater Minneapolis Area

Type: Full-Time, Leadership (100% Onsite)

The Opportunity

A premier Life Sciences employer in the Greater Minneapolis area is seeking a high-caliber visionary Operations Director to lead a sophisticated manufacturing facility. This strategic leader will oversee all site operations: from engineering and warehouse to production and distribution. Ensuring the delivery of life-enhancing implants and products. The successful candidate will cultivate a culture of "Zero Incidents," maintain rigorous regulatory compliance, and drive a world-class Continuous Improvement engine. Due to the high-touch nature of our facility and the need for visible leadership, this position is 100% onsite. We are looking for a leader who doesn't just manage processes but inspires people.

Core Responsibilities

• Operational Leadership: Oversee all manufacturing, purchasing, engineering, and distribution activities. Manage production operations to maximize efficiency and achieve operating budget objectives.
• Performance Excellence: Own site-level performance across key KPIs: Safety, Quality, Delivery, Cost, Inventory, and People (SQDCIP).
• Strategic Alignment: Support total business revenue goals by aligning operations with commercial and marketing leadership. Implement operational strategies that support global corporate initiatives.
• Regulatory & Quality Stewardship: Ensure 100% compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements. Partner with Quality/Regulatory teams to ensure constant audit readiness.
• Continuous Improvement: Champion a culture of Lean Manufacturing and Six Sigma. Drive employee engagement at all levels to foster innovation and process optimization.
• Capital & Resource Management: Direct capital equipment requirements, ensuring the efficient use of materials and personnel to meet production demands.
• Product Lifecycle: Partner with R&D and Quality to manage the successful transfer and scale-up of new products, ensuring manufacturability and cost targets.

Requirements

• Education: Bachelor’s degree in engineering, Business, or a related technical field; a Master’s degree (MBA or MS) is highly preferred.
• Experience: 10 years of experience in a highly regulated processing or manufacturing facility, with at least 7 years in a significant leadership/management capacity.
• Technical Expertise: Deep understanding of ERP systems, budget management, and strategic planning.
• Operational Excellence: Lean Six Sigma certification or equivalent operational excellence training is strongly preferred.
• Regulatory Knowledge: Proven track record operating within highly regulated environments (FDA/ISO/GMP).
• Communication: Exceptional verbal and written communication skills with the ability to engage in a diverse workforce.

Compensation & Benefits

We believe in rewarding excellence. The company offers a comprehensive benefits package designed to support the holistic health and financial well-being of our leaders and their families. Competitive compensation for this role is commensurate with the candidate’s professional experience, leadership history, and educational background.