Job Responsibilities

·  Has primary function of operating workstations used in the manufacturing and prototyping process

·  Proficient in set up and loading component materials into product specific tools

·  Performs receiving and inspection activities per protocols

·  Has the responsibility of following established documentation for product manufacturing

·  Demonstrates strict adherence to all safety, GMP and quality system guidelines

·  Must accurately document all work performed on inspection reports and travelers

·  Possess the ability to read and follow process control documents, work instructions, and SOPs

· Performs visual inspection with and without use of microscopes in accordance with the requirements in process control docs or similar documentation

·   Ability to perform basic workstation set up and troubleshooting tasks

·   Maintains cleanliness of work areas, machines, tools, and equipment

·    Assists Quality Control as required

·    Assists engineering with equipment qualification, process validations and design verification testing

·    Responsible for recognizing quality issues and communicating to quality / management

·  Assists in varied low-level data entry and document facilitation activities in support of material management, quality records, equipment maintenance and records

Job Requirements

·   Excellent communication skills with ability to interface at all levels

·    Knowledge of ISO and FDA requirements

·    Ability to provide detail information to assist engineering in determining root cause in order to identify the appropriate corrective action

·    Must be able to read, write and speak fluent English

·    Associates Degree or minimum 3 year experience in medical device assembly or equivalent desired

·    Flexibility, adaptable, persistence, passion, resourcefulness, a drive to succeed, and an entrepreneurial spirit.