Plant Manager at Biomerics in Fairfield, CA

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 the lives of our employees and patients who depend on our products.

At Biomerics, we believe in integrity, partnership, empowerment and accountability, trust, agility, teamwork, and excellence, and we care. Our team-oriented, customer-focused corporate culture prioritizes building strategic, mutually beneficial partnerships with customers and our team members.

As a Plant Manager in the medical devices industry, you play a critical role in ensuring the efficient operation of manufacturing facilities that produce medical devices. Your responsibilities typically include overseeing production processes, maintaining quality standards, ensuring compliance with regulatory requirements, and managing staff. Here’s a more detailed breakdown of what the role involves:

Responsibilities: (50,000 sq ft plant, 105 employees)

Production Management:

• Oversee the daily operations of the manufacturing plant.
• Develop and implement production plans to meet demand forecasts.
• Monitor production schedules and adjust as needed to ensure timely delivery of products.

Quality Assurance:

• Ensure that all products meet the required quality standards and regulatory requirements (e.g., FDA, ISO 13485).
• Implement and monitor quality control procedures.
• Investigate and resolve any quality issues or product defects.

Regulatory Compliance:

• Ensure the plant complies with all relevant regulations and standards.
• Maintain documentation and records for regulatory inspections and audits.
• Implement changes and improvements based on regulatory updates.

Staff Management:

• Lead, train, and develop a team of production staff and supervisors.
• Handle recruitment, performance reviews, and staff development.
• Foster a positive and productive work environment.

Operational Efficiency:

• Identify and implement process improvements to increase efficiency and reduce costs.
• Manage inventory levels and control costs associated with production.
• Utilize lean manufacturing principles to optimize workflows.

Safety and Environmental Compliance:

• Ensure the plant adheres to safety regulations and practices.
• Implement safety programs and conduct regular safety audits.
• Manage environmental impact and ensure compliance with environmental regulations.

Maintenance and Equipment Management:

• Oversee the maintenance of manufacturing equipment and facilities.
• Ensure equipment is functioning properly and efficiently.
• Coordinate repairs and upgrades as necessary.

Budget and Financial Management:

• Develop and manage the plant budget.
• Monitor financial performance and implement cost-saving measures.
• Prepare reports on plant performance and financial metrics.

Skills and Qualifications:Educational Background:

• A bachelor's degree in engineering, manufacturing, business management, or a related field is typically required. Advanced degrees or certifications in quality management or operations may be advantageous.

Experience:

• Several years of experience in manufacturing, with a focus on medical devices or a related field.
• Proven experience in a leadership or management role within a manufacturing environment.

Technical Skills:

• Knowledge of manufacturing processes, quality control, and regulatory requirements specific to medical devices.
• Proficiency in using manufacturing software and tools.

Leadership and Management Skills:

• Strong leadership abilities with experience in managing teams and driving performance.
• Excellent communication, problem-solving, and decision-making skills.

Attention to Detail:

• High attention to detail to ensure compliance with strict regulatory standards and quality requirements.

Project Management:

• Ability to manage multiple projects simultaneously and meet deadlines.

In summary, as a Plant Manager in the medical devices industry, you are responsible for overseeing the entire manufacturing process, ensuring product quality and regulatory compliance, managing staff, and improving operational efficiency. Your role is crucial in maintaining the high standards required for medical device production and ensuring the safety and efficacy of the products manufactured.

Additional Skills:

• Thermal forming
• Liquid Resin Casting
• Project Recovery Experience
• Time management, leadership, and problem-solving skills are essential.
• 3-5 years of experience with:
• Continuous Improvement
• Lean Manufacturing
• Toyota Production System
• Danaher Business System preferred