Medical Device Assembly Specialist Position Available In Norfolk, Massachusetts

Medical Device Assembly Specialist 5.0 5.0 out of 5 stars Foxborough, MA 02035 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.

Benefits:

Competitive salary and benefits package. Opportunities for career advancement and professional development. A supportive and collaborative team environment.

FLS Job Type:

Temporary Pay:

$20.00 – $22.00 per hour

Schedule:

Day shift Evening shift

Work Location:

In person