Job Description – Manufacturing Manager
This critical role involves managing a team of skilled professionals, ensuring regulatory compliance, maintaining strict quality control, optimizing manufacturing processes, and meeting production goals.
Responsibilities (Essential Duties and Responsibilities):
- Develop and execute production plans to meet customer order delivery and internal inventory requirements. Communicate production schedules and progress against the schedules to senior management and to customers.
- Promote and enforce a safe working environment by adhering to OSHA regulations and company safety policies. Conduct safety training and ensure proper safety equipment and practices are followed.
- Ensure the timely and efficient supply of raw materials and components required to meet production and cost objectives.
- Manage the planning, preparation, and shipment of customer orders to achieve on-time delivery objectives.
- Manage and allocate human and material resources efficiently to optimize production efficiency. Monitor and control production costs while staying within budget constraints.
- Recruit, train, and supervise production and warehouse staff. Provide guidance, mentorship, and performance feedback to ensure a skilled and motivated workforce.
- Develop and maintain a structured training program for staff and career pathways to promote career growth and retention.
- Continuously identify opportunities for process optimization, cost reduction, and waste reduction. Implement lean manufacturing principles and Six Sigma methodologies to streamline operations.
- Work in conjunction with the Quality department to implement and maintain quality control processes to adhere to FDA and other relevant regulatory standards. Oversee the implementation and adherence of Good Manufacturing Practices (GMP) and ISO standards. Conduct audits and inspections to ensure compliance and address any quality issues promptly.
- Identify capital equipment needs and solutions, working with the accounting department to perform cost-benefit analysis to justify procurement. Manage the process of procurement and implementation into the production workflow.
- Participate in company budgeting activities.
- Stay informed about industry trends, technological advancements, and best practices in medical device manufacturing. Attend workshops, conferences and training programs to enhance skills and knowledge.
Responsibilities (Non-Essential Duties and Responsibilities):
- Maintain accurate inventory records in the Enterprise Resource Planning (ERP) system. Maintain lot traceability of materials to meet regulatory requirements. Implement inventory control measures to minimize stockouts and excess inventory.
- Generate regular reports on production metrics, quality, and performance for senior management and regulatory agencies. Maintain accurate production records, including device history records and batch records.
Minimum Required Qualifications (Knowledge, Skills, and Abilities):
- Bachelor’s degree in an Engineering field.
- At least 3 years of experience working in manufacturing in a regulated environment
- Demonstrated leadership capabilities, including supervising cross-functional teams, training team members, and driving and communicating results.
- Proficiency in using ERP systems for production planning, purchasing, and inventory management.
- Thorough understanding of health and safety regulations.
- Expert knowledge of Microsoft Office products (Word, Excel, and PowerPoint).
- Ability to work under pressure and meet strict deadlines.
- Strong organizational skills and attention to detail. Must be able to manage time and efficiently transact business in a fast-paced environment.
- Effective business writing skills
- First class communication and interpersonal skills. Must be able to work effectively with people at all levels of the organization.
Preferred Qualifications (Knowledge, Skills, and Abilities):
- A demonstrated track record of progressive roles within a manufacturing environment
- Experience in the medical device industry working with Good Manufacturing Practices (GMP)
- Familiarity with FDA regulations, ISO standards, and Quality Management Systems
