Overview

This position will manage day-to-day production activities and resources necessary to produce quality and cost-effective products that meet or exceed customer’s expectations. Oversees the implementation, maintenance and improvement of manufacturing methods, processes, and operations for new and existing products. Manages work assignments in staffing, scheduling, coordinating, and planning of personnel engaged in production and maintenance.

Responsibilities

· Facilitates effective use of materials, equipment, and personnel in producing quality products.

· Initiates safety, cost-savings, Lean Manufacturing, and Kaizen for continuous improvement.

· Manages appropriate production staff levels, schedules, and resources.

• Selects, develops, manages, and evaluates production personnel.
• Makes sound decisions about work assignment, equipment use and procurement.
• Ensure coordination between relevant areas of manufacturing such as production control, procurement, and shipping.

· Assists with associate training and competency in adherence to 21CFR 820 and ISO 13485:2016

· Ensure implementation and adherence to health and safety procedures.

· Ensure implementation and adherence to quality procedures.

· Coordinates efforts with associates to reach or exceed establish standards of production, including quality, efficiency, waste reduction, machine downtime, etc.

· Develops and/or updates manufacturing operating and training procedures with uniformity

· Understands and supports efforts to manage overall operating budget and increase operational efficiencies.

· Engages with OEM customers as required to update on production scheduling.

· Other duties as assigned.

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Qualifications

Education and/or Work Experience Requirements:

· Bachelor’s degree in Industrial Engineering or equivalent combination of experience and education.

· A minimum of ten (10) years’ experience in a Medical Device manufacturing environment.

· A minimum of five (5) years of direct supervisory and/or managerial experienced is required.

· Good understanding of FDA 21CFR 820, ISO 13485:2016, EU MDR, and cGMP requirements and regulations.

· Excellent written and verbal communications skills.

· Bilingual (English and Spanish) a plus, but not required

· Ability to use MS Word, Excel, Power Point, ERP, and electronic email systems.

· Excellent people skills, with an advanced understanding of team building concepts.

· Strong ability to achieve high level performance by setting clear expectations and holding people accountable.

· Ability to align department objectives with corporate objectives.

· Experience working in a medium volume, high product mix environment is a plus.

· Knowledge and implementation of 5S techniques and Lean Manufacturing concepts.

Physical Requirements:

· Regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.

· Frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.

· Ability to lift 35 pounds.

· Specific vision abilities required by this job include Peripheral vision and Depth perception.