Assembler

Spectrum Plastics Group; New Brighton (MN); On-site; USD 25,000 - 34,000; Full time

Job summary

Spectrum Plastics Group in New Brighton, MN is seeking a Full Time Medical Device Assembler to join a certified clean room team. You will assemble devices, inspect components, and record data in SPC software, ensuring quality and throughput in a regulated environment.

Requires 1+ year of clean room experience and a high school diploma or GED. You will train others, follow work instructions, and maintain safe, organized workstations in a collaborative team.

Qualifications

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

Responsibilities

• Follow clean room practices in certified areas.
• Assemble medical devices and components per work instructions.
• Inspect and test devices per inspection plans.
• Enter inspection data into SPC software where required.
• Label products and packaging with labeling, IFUs, and warranty cards.
• Laser mark traceability information on product.
• Operate automated assembly and packaging equipment.
• Maintain cleanliness of workstations and perform cleaning as prescribed.
• Assist in training Manufacturing Associates on item numbers.
• Protect confidential information and comply with safety manual.

Skills

Attention to detail

Dexterity

Instruction following

Train others

Education

High school diploma or GED

Job description

Job Details: Job Location: Donatelle - New Brighton - New Brighton, MN, Position Type: Full Time, Salary Range: $18.00 - $25.00Hourly, 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

Qualifications: