Plant Manager

Biomerics•Fairfield, CA

8d•Onsite

About The Position

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: 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.

Requirements

A bachelor's degree in engineering, manufacturing, business management, or a related field is typically required.
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.
Knowledge of manufacturing processes, quality control, and regulatory requirements specific to medical devices.
Proficiency in using manufacturing software and tools.
Strong leadership abilities with experience in managing teams and driving performance.
Excellent communication, problem-solving, and decision-making skills.
High attention to detail to ensure compliance with strict regulatory standards and quality requirements.
Ability to manage multiple projects simultaneously and meet deadlines.
Time management, leadership, and problem-solving skills are essential.
3-5 years of experience with: Continuous Improvement
3-5 years of experience with: Lean Manufacturing
3-5 years of experience with: Toyota Production System
3-5 years of experience with: Danaher Business System preferred

Nice To Haves

Advanced degrees or certifications in quality management or operations may be advantageous.
Thermal forming
Liquid Resin Casting
Project Recovery Experience

Responsibilities

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.
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.
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.
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.
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.
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.
Oversee the maintenance of manufacturing equipment and facilities.
Ensure equipment is functioning properly and efficiently.
Coordinate repairs and upgrades as necessary.
Develop and manage the plant budget.
Monitor financial performance and implement cost-saving measures.
Prepare reports on plant performance and financial metrics.