Summary

Spectrum Plastics Group is a leading global manufacturer of specialty medical device components and assemblies, serving the healthcare industry with precision-engineered plastic solutions. The company specializes in the design, development, and manufacturing of critical components for medical devices across various therapeutic areas including cardiovascular, surgical, diagnostic, and drug delivery applications. With expertise in advanced polymer processing technologies, Spectrum provides custom solutions that meet stringent regulatory requirements and quality standards essential for medical applications. Their comprehensive capabilities encompass extrusion, injection molding, balloon catheter manufacturing, and complex assembly operations, supporting medical device OEMs in bringing innovative healthcare solutions to market. The company's focus on quality, reliability, and technical innovation has established it as a trusted partner in the medical device supply chain, contributing to improved patient outcomes through precision-engineered components that meet the demanding requirements of modern medical technology.

Job description

Overview of Responsibilities

Follow rigorous clean room practices for working inside certified clean room assembly areas
Assemble finished medical devices and medical device components per work instructions
Inspect and test medical devices per documented visual inspection requirements and inspection plans
Accurately fill out forms such as travelers and component reconciliation forms
Enter inspection and testing data into SPC software where required
Label product with medical device labeling, install instructions for use, warranty cards, etc. into device packaging
Laser mark traceability information on product
Operate automated medical adhesive dispensing equipment and other various assembly equipment
Operate tray sealing and pouch sealing equipment and inspect for packaging integrity
Wipe down/clean workstations at prescribed intervals
Perform medical washing operations where required
Use microscope and/or vision system for complex inspections per work instructions
Consistently meet product quality requirements and throughput rate expectations
Assist in providing part specific training for Manufacturing Associates who are not trained on specific item numbers (ongoing)
Responsibility to protect Donatelle confidential information and Intellectual Property
Follow safety requirements as outlined in the safety manual
Perform other projects and duties as assigned

Preferred Qualifications

Education/Experience

1+ years of relevant experience assembling medical devices in a clean room environment
High school diploma or GED preferred

Other Qualifications and Desired Skills

High attention to detail
Good dexterity and ability to assemble components of varying sizes
Good comprehension of written and verbal instruction and be able to articulate these instructions to others when training
Work with minimal supervision
Understanding of cGMPs and ISO standards
Understanding of the importance of proper line clearance
Ability to use computer for entering of inspection and test data

Requirements

1+ years of relevant experience assembling medical devices in a clean room environment
High school diploma or GED preferred
High attention to detail
Good dexterity and ability to assemble components of varying sizes
Good comprehension of written and verbal instruction
Work with minimal supervision
Understanding of cGMPs and ISO standards
Understanding of the importance of proper line clearance
Ability to use computer for entering of inspection and test data

Company overview

Spectrum Plastics Group is a leading global manufacturer of specialty medical device components and assemblies, serving the healthcare industry with precision-engineered plastic solutions. The company specializes in the design, development, and manufacturing of critical components for medical devices across various therapeutic areas including cardiovascular, surgical, diagnostic, and drug delivery applications. With expertise in advanced polymer processing technologies, Spectrum provides custom solutions that meet stringent regulatory requirements and quality standards essential for medical applications. Their comprehensive capabilities encompass extrusion, injection molding, balloon catheter manufacturing, and complex assembly operations, supporting medical device OEMs in bringing innovative healthcare solutions to market. The company's focus on quality, reliability, and technical innovation has established it as a trusted partner in the medical device supply chain, contributing to improved patient outcomes through precision-engineered components that meet the demanding requirements of modern medical technology.