Job Description:

Responsibilities:

• Perform direct labor to produce and/or qualify XSTAT device components and convenience kits.
• Operate manufacturing and lab equipment associated with the production and qualification of XSTAT components.
• Understand and follow current safety policies, manufacturing processes and other written procedures.
• Thoroughly and accurately complete manufacturing documentation.
• Perform data entry using Microsoft Excel.
• Perform instrument calibration, maintenance and validation activities as instructed.
• Inform Production Manager/Lead Manufacturing Technician of employee, product, and process issues.
• Adhere to FDA (21 CFR 820) and ISO (ISO 9001 or ISO 13485) quality system guidelines.
• Participate in regular team meetings.
• Stay up to date on training of all applicable procedures.

Receive instruction on routine work and on new assignments.

Qualifications/Experience:

• Associate’s Degree in a scientific discipline with no experience; or High school diploma with at least 2 years related experience in technology-oriented manufacturing or laboratory environment.
• Veterans with no college degree require a minimum of 2 years of service with an honorable discharge, or actively in the National Guard.
• Possess fine motor skills (able to work with small parts).
• Able to follow written procedures and complete documentation thoroughly.
• Able to perform basic data entry with Microsoft Excel.
• Able to lift 25 pounds.
• Experience with document control within a FDA (21 CFR 820) or ISO (ISO 9001 or ISO 13485) quality system is preferred.
• Experience in medical device manufacturing is preferred.
• Experience with mechanical and automated equipment is preferred.

Required Skills/Behaviors

• Good communicator
• Team player, assist others
• Maintain a strong work ethic (diligent, responsible and punctual)
• Maintain attention to detail
• Able to multi-task
• Willingness to be flexible and adaptable in a fast-paced and changing environment
• Willingness to work overtime based on production needs
• Able to work on assignments that require judgment and initiative
• Able to work with hazardous chemicals
• Able to operate independently or with others