Product Assembler

Production Assembler

Vortran Medical Technology 1, Inc. – Sacramento, CA

Job Summary

Vortran Medical Technology 1, Inc., a Class II medical device manufacturer, is seeking a detail-oriented and quality-focused Production Assembler to join our growing team. In this role, you will assemble precision respiratory medical devices and components in accordance with FDA regulations, ISO 13485 standards, and internal quality system requirements.

As a Production Assembler at Vortran, you play a critical role in ensuring our life-support and respiratory products meet the highest standards of safety, performance, and reliability. This position requires strong attention to detail, adherence to controlled work instructions, and commitment to quality in a regulated manufacturing environment.

Essential Duties & Responsibilities

Assemble medical device components and finished goods according to approved work instructions, Device History Records (DHRs), and Standard Operating Procedures (SOPs)

Perform precision assembly using hand tools, fixtures, and mechanical components

Complete production documentation using Good Documentation Practices (GDP)

Conduct in-process inspections and final quality checks

Identify and report nonconformances to supervisors or Quality Assurance

Maintain lot traceability and accurate documentation of materials used

Assist with packaging and labeling of finished goods

Maintain a clean, organized, and compliant workspace

Support inventory tracking and material control

Qualifications & Skills

Experience in manufacturing or assembly (medical device or regulated industry preferred)

Ability to follow detailed written instructions and controlled documentation

Strong manual dexterity and mechanical aptitude

Excellent attention to detail

Ability to work independently and as part of a team

Ability to stand for extended periods and lift up to 30 lbs

Familiarity with FDA-regulated or ISO 13485 environments is a plus

Work Environment

Manufacturing facility environment

Use of Personal Protective Equipment (PPE) as required

Strict adherence to safety and quality system standards

Pre-Employment Requirements

Employment with Vortran Medical Technology 1, Inc. is contingent upon:

Successful completion of a background check conducted in accordance with applicable federal and California laws

Successful completion of a pre-employment drug screening, where permitted by law

Verification of employment eligibility

Why Join Vortran?

At Vortran, our products support respiratory care worldwide. Every device assembled contributes directly to patient safety and clinical performance. We are committed to regulatory excellence, teamwork, and continuous improvement.

Join a mission-driven company where quality and accountability matter.