Assembly Technician

We are seeking an experienced and detail-oriented Assembly Technician to join our team and contribute to the assembly of high-quality medical devices. In this role, you will use a variety of hand tools, power tools, soldering irons, and specialized equipment to assemble products in a cleanroom environment. You will follow detailed work instructions to ensure that all devices meet strict regulatory and quality standards. The ideal candidate will have experience working in a regulated manufacturing environment, with strong attention to detail and excellent manual dexterity.

Key Responsibilities:

Assembly and Fabrication:

• Assemble medical devices using hand tools, power tools, soldering irons, and optical microscopy.
• Mix two-part solutions to precise volumes to support molding and joining processes.
• Set up and operate ultrasonic welders, pneumatic presses, and heat-sealing equipment.
• Perform cleaning, pouching, sealing, and labeling of sterile products in compliance with quality standards.

Cleanroom Compliance:

• Work full-time in a Class 7 cleanroom environment, adhering to all gowning and contamination control procedures.
• Maintain cleanliness of work areas and equipment to meet GMP (Good Manufacturing Practices) standards.
• Ensure compliance with all safety and regulatory guidelines for cleanroom operations.

Measurement and Documentation:

• Accurately measure and mix components using laboratory equipment such as graduated pipettes and cylinders.
• Follow detailed work instructions and document all assembly processes, inspections, and product testing in compliance with ISO 13485 and FDA 21 CFR 820.
• Support line clearance and start-up activities, ensuring that all production processes are completed to specification.

Production Support and Maintenance:

• Perform machine setups, routine maintenance, and troubleshooting on equipment.
• Participate in scheduled maintenance tasks and contribute to the continuous improvement of manufacturing processes.

Team Collaboration:

• Work both independently and as part of a team to meet production goals and timelines.
• Communicate effectively with other team members and departments to ensure smooth operations and address any production issues.

Qualifications and Requirements:

Education:

• High School diploma or equivalent required.

Experience:

• 3 to 7 years of experience in a regulated manufacturing environment.
• Previous experience in an ISO 13485 and FDA-compliant (21 CFR 820) manufacturing environment preferred.
• Familiarity with MS Office, including proficiency with Access databases for tracking and reporting purposes.

Skills & Abilities:

• Excellent manual dexterity for assembly of small parts using tools and optical microscopy.
• Ability to perform precise measurements and mix solutions with accuracy.
• Comfortable working in a Class 7 cleanroom environment and following gowning procedures.
• Strong problem-solving skills and ability to troubleshoot equipment issues.
• Ability to work independently and take initiative while also being a collaborative team player.
• Demonstrated success in planning and executing complex assembly production workflows.

Physical Requirements:

• Ability to stand for extended periods of time and lift up to 25 lbs.
• Ability to perform repetitive tasks with attention to detail.

FLS

Job Type: Contract

Pay: $23.00 - $25.00 per hour

Education:

• High school or equivalent (Required)

Experience:

• Asssembly: 2 years (Required)
• Cleanroom: 2 years (Required)

Ability to Commute:

• Foxborough, MA 02035 (Required)

Work Location: In person

Salary : $23 - $25