Responsible for overseeing all manufactured products, value-added services, and manages the day-to-day operations of the organization's manufacturing facilities, planning, coordinating, and directing the activities (processes) that result in finished good products. The job encompasses manufacturing, work scheduling, managing production staff, work procedures, and quality. In addition, Capacity Scheduling, Ramp Up activities, Budget adherence, goals setting, performance reviews, and Continuous Improvements Project to improve Production Metrics. Manufacturing Manager will work closely with R&D, Clinicals, and Supply Chain to assure build plan/inventory adherence.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Responsibility and ownership of clean room assembly and test activities as well as overseeing effective Clean Room operating practices.
Coordinate personnel, test equipment and instruments to fulfill production build plan and ensures that production schedules are maintained, and product quality is acceptable by ensuring that production meets the highest standard of quality.
Plan and determine optimal utilization of manufacturing workers and equipment to meet manufacturing goals.
Working with your team, identify and act on opportunity to drive improvement within Manufacturing.
Regularly evaluates operational efficiency and makes necessary changes to maximize staff and operational productivity.
Plans, schedules, and manages one or more manufacturing production process.
Assists with planning and directing an efficient layout of equipment and flow of materials.
Ensure manufacturing floor is in compliance with all safety regulations.
Hire and train new staff members and maintains a staffing schedule.
Develop and build a successful production operations team ensuring that the necessary staff, competence, skill, knowledge, and tooling are available to deliver production targets.
Maintains inventory control and communicates levels to management, purchases inventory items and interfaces with vendors.
Effectively communicate status, timelines, and critical issues to all levels of the organization.
Develop standard operating procedures and assist in implementation. Revise manufacturing documentation, processing documents, SOPs, etc.
Will liaise with, and support R&D and Quality relative to new product introduction.
Serve as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies.
Advise the leadership team of factors that may affect quality of the product, initiate reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)
Manage Capacity Planning to assure build plan is meet
Owns hiring and training plan for Product Builders and Production support team
Creates Labor Event Chart to forecast improvements in Labor Standard
Supports/Creates Productivity Projects to improve Financials of the Operation
Owns Ramp Up/Down plans to meet demand
Lead Industrial Engineering and Training Department
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
Bachelor's degree in business, manufacturing, or engineering
5+ years production management experience in a Medical Device manufacturing environment, ideally with a cleanroom environment.
Manufacturing of catheter products a plus
Good understanding of Current GMPs and ISO13485 standards.
KNOWLEDGE, SKILLS AND ABILITIES:
Continual improvement process experience
Strong communication and organizational skills
Ability to work well with people at all levels
A thorough understanding of Clean Room requirements
Ability to lead a diverse team of manufacturing workers