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

Other

Performs other duties as assigned

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

Ability to effectively train work group and lead work teams within the work group

Ability to work well with and mentor both high and low performers in a team or group environment, setting expectations, and providing input and feedback in a helpful way that fosters accountability

Must be able to read, write and speak fluent English

Minimum 2-5 years of experience in medical device assembly or equivalent desired

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

CORE COMPETENCIES

Communication Skills

All verbal and written communications are concise, technically accurate, timely, and professional.  Demonstrates strong verbal presentation and negotiation skills. Represents in a positive and professional manner.  Expresses ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrates tact and diplomacy in communications. Demonstrates active listening skills and ability to resolve discrepancies with customers

Management of Resources

Well organized and uses time efficiently. Familiar with all reference materials and can locate needed information as necessary.  Takes initiative for self-development. Prioritizes tasks effectively. Demonstrates initiative and creativity in the use of available resources.

Customer Focus

Provide professional, reliable and prompt service to internal and external customers Work in partnership with others to meet and exceed customer expectations. Interpret customer needs and take appropriate action. Follow through on customer inquiries in a professional and timely manner.