Job Description

Job Title

Key Responsibilities:

• Perform development and packaging processes in a lab environment following standard operating procedures (SOPs) and good manufacturing practices (GMPs)
• Assist in completing test protocols and procedures, operating test equipment, and recording measurements with limited supervision for the R&D and NPD areas.
• Complete device history records and associated paperwork for preexisting inventory and products accurately
• Daily use of Lab tools and equipment such as pin gauges, micrometers and other measurement related equipment and precision devices for pilot manufacturing processes.
• Maintaining lab equipment, managing new equipment and inventory while confirming all equipment is accurately calibrated and in working order.
• Provide process/test method training to internal manufacturing/quality control personnel.
• Assist in training new external personnel including full-time and subcontractors.
• Assist with other projects as needed

Minimum Qualifications:

• High school diploma or equivalent experience with 2 years' experience in a laboratory setting with basic knowledge of daily laboratory procedures, equipment utilization, setups, processes, device testing and safety protocols
• Basic math/statistics skills
• Good working history and experience using Microsoft Excel
• Ability to accurately collect, record, and report data and transcriptions.
• Familiar with and having the ability to operate and use lab tools and equipment (rulers, pressure gauges, micrometers, and tensile testers and more)
• Comfortable communicating verbally and in written form, presenting data, and information.
• Willing to work independently and meet deadlines with little supervision.

Desired Qualifications:

• Associate's degree or equivalent experience in a S.T.E.M related field
• Previous experience testing medical device in regulated FDA/QSR and ISO environments.
• Hands on experience and interest with mechanical aptitudes

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