Assembly Technician

ICES: Data, Discovery, Better Health; Baltimore (MD); On-site; USD 34,000 - 52,000; Full time

Job summary

Novel Microdevices seeks an Assembly Technician to manufacture sub-assemblies and final assemblies of medical devices in a cleanroom environment. Under direct supervision, you will clean, assemble, inspect, and package devices following SOPs.

After training, you will operate with minimal instruction, report issues promptly, and maintain batch history records, logs, and safety practices. The role requires detail, manual dexterity, and ability to lift up to 25 lbs.

Qualifications

• Must follow written directions found in SOPs and work instructions.
• Accurate Batch History Records entry and documentation.
• Maintain cleanroom standards and GMP practices.
• Perform quality inspections on materials and finished goods.
• Lift up to 25 lbs and stand for extended periods; avoid repetitive strain.
• Ability to work with chemicals or reagents as required.

Responsibilities

• Follow SOPs and work instructions to assemble sub-assemblies and final products; record on Batch History Records.
• Maintain cleanroom standards, practices and housekeeping per GMP guidelines.
• Cut and clean plastic parts for biological sample contact.
• Inspect and record quality of materials, sub-assemblies, and finished goods.
• Perform additional duties like machine maintenance, packing, and inventory handling.
• Adhere to safety policies and keep work area clean.
• Operate and maintain equipment; use microscopes, tweezers, and hand tools.
• Identify issues with equipment or documentation and report immediately.

Skills

Follow SOPs

Fine motor skills

Independent after training

Oral & written communication

Detail-oriented

Basic math

Education

High school diploma

Associate's or higher in technical field

Tools

Microsoft Word

Excel

Job description

POSITION SUMMARY: Novel Microdevices is seeking a Assembly Technician to help manufacture sub-assemblies and final assemblies of medical devices. Under direct supervision, the selected candidate cleans, assembles, inspects and packages medical devices following standard operating procedures, and performs other manufacturing activities and maintenance.

This production is conducted inside of a cleanroom environment, and requires wearing a gown, gloves, hair net, face mask, and shoe coverings. The assembly technician must pay attention to detail as the y conduct visual inspections and in-process quality checks.

After initial training, the assembly technician should be able to operate independently with minimal instruction. The assembly technician must be able to communicate any issues they encounter in the assembly process.

PRIMARY DUTIES:

• Follow standard operating procedures and work instructions while manufacturing sub-assemblies and final assemblies of medical devices. Record work on Batch History Records. Maintain work logs as needed.
• Maintain cleanroom standards, practices, and housekeeping following good manufacturing procedures.
• Cut and clean plastic parts using proper technique to support biological sample contact.
• Perform and record quality inspections of materials, sub-assemblies, and finished goods following the standard operating procedures and work instructions.
• Perform other duties as assigned such as machine maintenance, record keeping, packing, and storing inventory, etc.
• Understand and adhere to safety policies and practices.
• Clean and maintain equipment and work area as needed.
• Use tools such as microscopes, tweezers, and other hand-held tools.
• Recognize issues with the equipment and documentation and take appropriate corrective action within scope. Notify management of issues and discrepancies immediately.

REQUIRED SKILLS:

• Ability to follow written directions found in standard operating procedures and work instructions.
• Fine motor skills (hand/eye coordination) to place small parts onto assemblies using tweezers.
• Ability to work independently with minimal instruction after training has been completed.
• Effective oral and written communication skills including the ability to accurately record work on Batch History Records and other documentation.
• Detail-oriented
• Ability to solve basic math problems

DESIRED SKILLS:

• Experience in assembly or manufacturing in the medical device, pharmaceutical, or biotech industry.
• Experience working in clean rooms or laboratories.
• Experience using Microsoft Word and Excel

EDUCATION:

• Minimum of high school diploma. Preference given to those holding an Associate's or higher degree or certification in a technical field.

PHYSICAL ABILITY:

• Must be able to lift 25 lbs. Must be able to stand for several hours. Work may involve repetitive arm and wrist motions.
• Ability to work directly with, handle, or come into contact with chemicals or reagents.

TRAVEL REQUIREMENTS:

None

JOB TYPE:

Full-time, hourly