Job Summary
This is a full-time non-exempt position. Responsible for manufacturing and assembly of clinical and commercial products. Utilizing attention to detail, the Instrument Production Technician I operates production equipment and assembles instrument components using fine motor dexterity. Responsible for performing a wide variety of electronic or electro-mechanical assembly operations on sub-assembly components. Has knowledge of commonly used cGMP concepts, practices, and procedures within the medical device field. Relies on instructions and pre-established guidelines to perform the functions of the job. Works under immediate supervision and reports to the BFDX Production Supervisor.
Essential Job Duties and Responsibilities
1. Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
2. Manufactures and assembles sub-assembly components products.
3. Prepare and package all finished goods for clinical and commercial products.
4. Operates production equipment.
5. Responsible for maintaining parts and materials in production lab area.
6. Maintains records that comply with regulatory requirements, Good Manufacturing Practices, and Standard Operating Procedures.
7. Performs in-process testing as needed to assure product meets specifications.
8. Required to interact with various company departments.
9. Performs other duties as assigned.
Qualifications
Training and Education
High School diploma, vocational training or equivalent.
Experience
This is an entry-level role. No previous experience is required; however, previous directly related experience is preferred (i.e. Ability to use specialized equipment, read instructions, maintain written records, and work from established drawings).
Knowledge, Skills and Abilities
Basic mathematics skills. Familiarity with ESD programs and clean room manufacturing desired. Experience with electronic or electro-mechanical assembly and soldering desired.
Physical Requirements
Able to lift a minimum of 25 lbs.