DFM Production Associate

Production Associate As a Medical Device Kitting/Production Associate at Polymedco, you will play a crucial role in assembling and packaging life-saving colorectal cancer (CRC) FIT kits. These kits are essential for early cancer detection, making a real difference in patients' lives. You'll be part of a dedicated team ensuring that every kit meets our high-quality standards and is ready for use in medical practices nationwide. This role is perfect for individuals who enjoy working with their hands, take pride in attention to detail, and thrive in a team environment. This is a Monday through Friday position.

Key Responsibilities:

Kit Assembly:

Manually or using automated equipment, assemble diagnostic kits according to Standard Operating Procedures (SOPs) and DHR (Device History Records).

Quality Inspection:

perform visual inspection of PHI (Protected Health Information) to ensure patient unique components match prior to assembling the kit. For barcoded patient unique components, scan barcodes into Spot Health Software to verify positive match. Escalate any PHI discrepancies or breaches immediately to DFM Supervisor to ensure compliance and proper handling of PHI.

Labeling & Documentation:

Accurately apply labels and document batch records in real-time, following Good Documentation Practices (GDP) for full traceability.

Compliance & Safety:

Adhere to FDA, ISO, and other regulatory requirements for medical device manufacturing and follow workplace safety guidelines.

Job Requirements:

Education:

High school diploma or GED required.

Experience:

1-2 years in a manufacturing or assembly environment preferred; experience in medical devices, biotech, or pharmaceuticals is a strong plus.

Dexterity:

Exceptional hand-eye coordination for handling small, delicate components.

Detail-Oriented:

Ability to follow complex, multi-step instructions without deviation to prevent product mix-ups.

Physical Requirements:

Ability to stand for long periods (8-10 hours) and lift up to 25-30 lbs.