PRIMARY PURPOSE OF POSITION:
Primarily responsible for ensuring the fulfillment of the production plan with finished product that meets Quality Control specifications. Responsible for manufacturing resources (staff & equipment); ensure capacity is available in equipment and trained personnel to meet the requirements of the business plan. Provide manufacturing support to R&D in relation to new product development and planned process improvements.
MAJOR DUTIES OF POSITION:
- Essential Duties and Responsibilities include the following:
- Ensure that production targets are met and yields are maintained consistently without any changes or drifts from established procedures.
- Develop efficiency improvement proposals and implement efficiency improvement plans.
- Reduce lens cost by improving process flow efficiency and improving capacity.
- Ensure equipment and personnel are available and trained to meet the forecasted production volume.
- Assist R&D/Engineering in documenting new manufacturing procedures and processes, implementing these changes, and training operators on new procedures.
- Assist R&D/Engineering in process improvement plans and trouble-shooting efforts.
- Work with Process Engineers and Engineering Technicians to ensure equipment and process validations are conducted in compliance with FDA, PMDA and ISO regulations.
- Work with Process Engineers and Engineering Technicians to bring new machinery/equipment to production floor in accordance with established procedures and regulatory requirements and train operators on equipment use.
- Establish and implement metrics of production performance.
- Document all work in accordance with the requirements of the AVS Quality System.
- Supervise and provide guidance and mentoring for production leads; work with HR to develop supervisory skills of this group.
- Manages all production floor staff. Carries out supervisory responsibilities in accordance with AVS policies and applicable laws.
- Monitor and control expenses against manufacturing budget to ensure that expenses are within budget.
- Ensure safety and compliance to OSHA.
- Provide GMP training for manufacturing staff.
- Other duties may be assigned.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Bachelor’s degree from four-year college or university in industrial engineering or mechanical/biomedical engineering discipline preferred, but not essential. At least five years experience in a similar regulated manufacturing environment is required. Additional work experience required in lieu of a degree.
- Solid knowledge of FDA & ISO 13485 regulations
- Solid knowledge of machining, molding, manual assembly methods, tooling & fixturing.
- Ability to solve practical problems
- Ability to calculate figures and to apply concepts of basic mathematics
- Must be detailed oriented and able to multi-task
- Possess solid computer skills
- Must be proficient in:
- Excel – create and work with spreadsheets
- Word – create and format professional correspondence
- Powerpoint – create meeting presentations
- Outlook – email & maintain company calendars
- ERP/MRP Manufacturing software
- Excellent verbal and written communication skills
- Must be dependable and flexible
- Must be a team player and have experience providing support for numerous internal customers
- Varied sitting, standing and walking
- Ability to lift and carry 50lbs. or less