Assembler II

Job Title: Assembler II

Job Location: San Diego, CA

Job Type: Contract

Pay Range: $14.70hr - $19.70hr

Job Overview:

The candidate will follow standard operating procedures and work instructions to build assemblies requiring precision, perform testing, calibration, and verification activities, and inspect components to ensure compliance with FDA guidelines and ISO standards. The role involves collaborating with cross-functional teams to resolve production discrepancies and maintaining detailed production records.

Responsibilities:

• Follow standard operating procedures (SOPs) and work instructions to perform wiring, component installation, cable mearnessing, and fitting of assembly instruments using hand and power tools, limited automated equipment, manufacturing aides/fixtures, lifts/cranes, and other methods within the manufacturing process.
• Build assemblies that require precise components, processes, and precision as part of instrument assembly build.
• Perform testing, calibration, and verification activities to ensure the accuracy, precision, and reliability of instruments, documenting the results accurately and in a timely manner.
• Inspect and verify the quality of components and finished products to ensure they meet specifications and comply with regulatory requirements, such as FDA guidelines and ISO standards.
• Troubleshoot and resolve production issues or discrepancies.
• Collaborate with cross-functional teams, such as engineering, quality assurance, business excellence, product development, and production supervisors, to provide feedback on product design, manufacturability, and process improvements to ensure smooth production flow.
• Document and record production activities, including assembly processes, product information, material control of critical parts, labeling activities, and quality non-conformance, accurately and in a timely manner.
• Actively work to achieve successful first-time-right completion of documentation.
• Follow company policies, procedures, and regulations, including quality management systems (QMS), good manufacturing practices (GMP), and safety regulations to maintain a safe, compliant, and productive work environment.
• Train other assemblers as required based on proven efficiency and demonstrated ability.
• Perform other duties as assigned.

Qualifications:

• High School Diploma / GED or equivalent requirement.
• Minimum 2 years of related assembly experience, preferably in the medical device or diagnostics industry.
• Familiarity with FDA regulations, ISO standards, and other relevant industry requirements is a plus.
• Strong technical skills in assembly, testing, and calibration of mechanical, electrical, and electronic components.
• 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, and measuring equipment.
• 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 including addition, subtraction, and multiplication.
• 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.
• Due to nature of job The candidate must have Ability to lift 50 lbs or more.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities