SUMMARY: Plans and coordinates work to higher level project schedules; develops longer term plans under

guidance; analyzes complex problems independently, coordinates cross-functional development and supplier

work. Responsible for creating, documenting, developing and implementing procedures used to assemble,

process, test and /or manufacture products. Will design, implement, monitor and maintain manufacturing

processes. Consult with design engineers in order to achieve the most efficient and cost effective way of

producing the highest quality product possible.

ESSENTIAL FUNCTIONS: The incumbent may be required to perform all or a combination of the following

essential functions as determined by business necessity.

Perform and report on evaluation testing, verification and validation in accordance with ISO, FDA and

corporate guidelines.

Estimate production times, staffing requirements, and related costs to provide information for

management decisions.

Confers with management and other staff regarding manufacturing capabilities, production schedules

and other considerations to facilitate production processes.

Apply statistical methods to trouble shoot processes and conduct root cause analysis.

Improve existing operations, incorporating new methods, processes and training.

Handle equipment purchase and installation, perform IQ/OQ and PQ functions.

Investigate operational problems affecting production and deal with them in a systematic, methodical

manner.

Prepare manufacturing documentation required for product manufacture.

Coordinate projects.

Identify ways to reduce production costs.

Work with R&D and other departments to produce cost estimates for new designs.

Work with regulatory bodies to ensure safety, environmental and design standards are met.

Serve as a team member in support of design for manufacturability.

Assist R&D in the transition of new products to production product status.

Generate and update assembly documentation (travelers/work instructions).

Process engineering changes (ECNs)

Control manufacturing costs by employing creative manufacturing and assembly methods (fixture

design).

Determine and review product cost.

Provide production floor support.

NON-ESSENTIAL FUNCTIONS: In addition to the essential functions listed above, the incumbent may be

required to perform other non-essential functions. Employees are required to follow any other job-related