Assembler I - 2nd Shift

TalentBurst•San Diego, CA

10d•Onsite

About The Position

This role involves following standard operating procedures (SOPs) and work instructions to perform various assembly tasks, including wiring, component installation, cable harnessing, and fitting of assembly instruments using a range of tools and equipment. The Assembler II is a progression role that builds assemblies requiring more components, processes, and precision, and may involve cross-training on instrument assembly build. Key responsibilities include performing testing, calibration, and verification to ensure instrument accuracy and reliability, inspecting components and finished products for quality and compliance with regulatory requirements (e.g., FDA, ISO), and troubleshooting production issues. The role also requires collaboration with engineering, quality, and product development teams for feedback and process improvements, as well as documenting production activities accurately and timely. Adherence to company policies, QMS, GMP, and safety regulations is essential. This position may also involve training other assemblers and performing other assigned duties.

Requirements

High School Diploma / GED or equivalent
Minimum 2 years related experience
Ability to interpret and understand technical drawings, instructions, and specifications to complete tasks
Proficient in using hand and power tools such as screwdrivers, wrenches, power drivers, measuring equipment, etc.
Detail-oriented with a high degree of accuracy and precision in work
Strong verbal and written communication skills
Working knowledge of standard computer programs.
Basic mathematical comprehension (addition, subtraction, multiplication, etc.)
Ability to work independently or as part of a team in a fast-paced, deadline-driven environment.
Good hand-eye coordination skills and mechanical aptitude.
Able to lift 50 lbs or more

Nice To Haves

Medical device or diagnostics industry preferred
Familiarity with FDA regulations, ISO standards, and other relevant industry requirements is a plus

Responsibilities

Follows standard operating procedures (SOPs) and work instructions to perform wiring, component installation, cable harnessing, fitting of assembly instruments, etc. using hand and power tools, limited automated equipment, manufacturing aides/fixtures, lifts/cranes, and other methods within the manufacturing process.
Performs testing, calibration, and verification activities to ensure the accuracy, precision, and reliability of the instruments, and documents the results accurately and timely.
Inspects and verifies the quality of components and finished products to ensure they meet specifications and comply with regulatory requirements, such as FDA guidelines and ISO standards.
Troubleshoots and resolves production issues or discrepancies.
Collaborates with other departments, such as engineering, quality, business excellence, and product development, to provide feedback on product design, manufacturability, process improvements.
Collaborates with cross-functional teams such as engineers, quality assurance, and production supervisors to ensure smooth production flow.
Documents and records production activities, including assembly processes, product information, material control of critical parts, labeling activities, and quality non-conformance, accurately and timely.
Actively works to achieve successful first-time right completion of documentation.
Follows company policies, procedures, and regulations, including quality management systems (QMS), and contributes to maintaining a culture of quality, compliance, and continuous improvement.
Follows good manufacturing practices (GMP), and complies with safety regulations to ensure a safe and productive work environment.
May be required to train other assemblers with proven efficiency and demonstrated ability.
Required to perform other duties as assigned.