The major function of this position is to propose, develop and perform optimization measures for manufacturing processes, equipment and software to continuously optimize manufacturing capacity, yield rate, productivity and cost-effectiveness, as well as manage new high-technology products introductions and ensure the production testing.
This engineering opportunity involves both a hands on position as well as the requirement to analyze, plan and steer projects in the day to day responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Identifies, plans and executes initiatives or projects to improve yield and productivity improvements with TPM team, technicians and production leads. Recommend plans to invest in certain equipment to support such initiatives or projects.
Independently manages projects to perform equipment and software optimization
Coordinate and perform equipment and software validations.
Manage all tasks related to introduction of new products in close cooperation with R&D team.
Has knowledge of U.S. and foreign medical device regulations, GMP, FDA, QSR’s, ISO 9000, CE Mark and ANSI standards.
Supports Operations and Quality Assurance in CAPA projects and root cause analysis to investigate productivity or quality issues
Definition, collection and review of production data and key performance indicators to support efficiency control in production on a daily basis and for trending purposes. Reports findings on a regular basis to Operations Management and initiates initiatives and projects to improve all areas of operations
Trains production staff in 5S, LEAN and Six Sigma initiatives and applies those principles to daily operations
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Strong mechanical background with “hands on” experience is a plus. Comfortable to work in a high volume with intense pace environment.
Ability to read, analyze and interpret documents such as safety rules, operating and maintenance procedures, engineering drawings, general business periodicals, professional journals, technical procedures, or governmental regulations and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to write routine reports and correspondence. Bilingual in Spanish a plus.
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations and mathematical functions.
Ability to define problems collects data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The work environment characteristics described here are representative of those an employee encounters while performing the
EDUCATION and/or EXPERIENCE
B.S. degree in Engineering (Preferably Industrial). Must have a minimum of 5+ years of experience in engineering tasks and managing engineering projects. Clean room experience and experience in the ophthalmic industry is a plus.