N2 Biomedical, a dynamic small company that has provided coatings for medical devices for nearly 30 years, is seeking a Production Manager. This position is a working manager, responsible for efficient coordination of workflow from incoming inspection through shipping in accordance with ISO-13485, FDA GMP, and internal/customer SOP’s. Candidates should possess mechanical capabilities as well as supervisory experience and a process improvement approach to the work environment.
N2 is a quick turn, high quality service business and requires an individual with both hands on and analytical skills with broad responsibilities ranging from production scheduling, lot configuration and setup and troubleshooting. Performance metrics are OTD, Customer Lot acceptance and Cost Variances.
This position reports to the COO with three shift supervisors and one inspection supervisor as direct reports. The individual will conduct training and performance reviews of production staff as necessary, and assure that training of the staff is accurate and up to date for the jobs being performed.
Experience in 5S and lean manufacturing is highly desirable.
Minimum requirements for the job are a Bachelor’s degree or equivalent related experience, and at least five years in a medical device environment with a minimum of 5 years supervisory experience. Direct experience with ISO/FDA GMP quality system requirements. The candidate must have effective leadership, organizational and communication skills to interact with other departments and direct/supervise the staff. A technical background and familiarity with vacuum coatings and processing equipment are a plus.