Operations Manager

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

POSITION SUMMARY

Responsible for production planning, production databases, inventory management, and overall production operations.

KEY RESPONSIBILITIES

Essential Functions

• Coordinate, develop, and execute the company's production control processes.
• Develop and maintain the necessary controls to ensure compliance with ISO 9001 and ISO 13485 standards across all supervised areas.
• Analyze relevant variables to provide accurate order confirmation dates to customers.
• Review quotations for new products in assembly operations in collaboration with the Engineering Department.
• Manage budgets related to quotations and ensure production line performance aligns with established quotations.
• Collaborate with the Engineering Department on the development of new projects.

Additional Responsibilities

• Create production orders and trip tickets once customer orders have been confirmed.
• Follow up on customer purchase orders.
• Ensure the production planning database is updated daily.
• Coordinate weekly production meetings.
• Coordinate shipments to meet customer delivery dates.
• Provide training on the intended use of products.
• Participate in material planning meetings with company customers.
• Follow up on customer complaints and corrective actions.
• Ensure compliance with departmental policies to support effective production planning and customer requirements.
• Carry out special projects as requested by the Vice President of Operations and General Manager.
• Maintain the Quality Management System in accordance with ISO 9001 and ISO 13485 standards.

KNOWLEDGE, SKILLS, AND COMPETENCIES

• Proactive mindset and strong leadership skills.
• Knowledge of ISO 9001 and ISO 13485 standards.
• Ability to develop costing and productivity systems.
• Proficiency in Windows and Microsoft Office.
• Ability to design and develop production process lines.
• Bilingual proficiency in Spanish and English.
• Knowledge of sterilization processes, handling of sterilized products, and proper product management.
• Strong customer communication skills.
• Extensive knowledge of logistics and international purchasing.
• Knowledge of Project Management Institute (PMI) methodologies and Six Sigma.
• Knowledge of Design of Experiments (DOE) and Lean Manufacturing.
• Familiarity with standard time evaluation techniques.
• Knowledge of and/or training in ISO 14971 (Risk Management).

EDUCATION AND EXPERIENCE

• Bachelor's degree in Mechanical, Industrial, or Electromechanical Engineering. A Master's degree in Business Administration (MBA) is preferred.
• Minimum of 3 years of experience in production management positions.
• Experience in personnel management.