Production Builder I

Penumbra•Salt Lake City, UT

28d•$18 - $23•Onsite

About The Position

Under supervision, the Production Builder I performs moderately complex assembly, data recording, and product testing. The role assembles medical devices and performs in-process inspections, documentation, equipment setup and operation, and cleanroom and work-area upkeep while following applicable quality, regulatory, safety, security, privacy, and compliance requirements. This position works onsite in a production lab or controlled environment room in a class 10,000 cleanroom. Personnel are gowned, and the role involves frequent microscope use.

Requirements

High school diploma or equivalent, plus at least 1 year of cleanroom assembly or manufacturing experience in the medical device, pharmaceutical, or biotech industry, or an equivalent combination of education and experience.
Basic math skills.
Ability to comprehend spoken and written English.
Effective verbal and written communication skills.
Close attention to detail.
High manual dexterity.
Basic working knowledge of cGMP/QSR requirements.
Ability to use tools such as a microscope, soldering iron, tweezers, and other handheld tools.
Willingness and ability to work onsite.
Ability to lift and move up to 25 pounds, move between buildings and floors, and remain stationary while using a microscope, cleanroom or laboratory equipment, or standard office equipment for extended periods.
Ability to use a computer for email, training, procedures, and related tasks.
Ability to communicate and exchange accurate information with employees at all levels on a daily basis.

Responsibilities

Assemble medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies.
Perform in-process inspections of components and assemblies to verify quality conformance.
Record information on lot history records and perform component accountabilities.
Set up and operate manufacturing equipment.
Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program.
Clean supplies, manufacturing equipment, and work areas.
Report causes of process or documentation issues and assist with their resolution.
Complete personal training records.
Adhere to the Company’s Quality Management System (QMS) and applicable domestic and global quality-system regulations, standards, and procedures.
Understand and follow applicable security, privacy, and compliance principles, regulations, standards, and procedures.
Ensure other department members follow the QMS and applicable regulations, standards, and procedures.
Maintain regular, reliable onsite attendance.
Perform other work-related duties as assigned.