Operator/ Machine Operator/ Assembler/ Cleanroom

Job Title: Operator II Medical Device Manufacturing
Location: Scarborough, ME 04074
Shift: 3rd Shift | Sunday Thursday | 10:00 PM 6:30 AM
Position Summary:
We are seeking an experienced
Operator II to join our medical device manufacturing team in Scarborough, ME. The successful candidate will be responsible for assembling, inspecting, testing, repairing, and packaging high-quality cardiovascular medical devices in a regulated manufacturing environment. This role requires strong attention to detail, excellent manual dexterity, and the ability to follow standardized work instructions while maintaining quality and safety standards.
Key Responsibilities:

• Assemble cardiovascular medical devices and related components according to documented procedures.
• Perform electronic, mechanical, casting/coating, and packaging operations.
• Operate manufacturing equipment and machinery safely and efficiently.
• Work in a cleanroom environment while adhering to GMP and quality standards.
• Utilize microscopes, hand tools, syringes, razor blades, soldering equipment, adhesives, and other precision tools.
• Conduct visual inspections and precision measurements to ensure product quality.
• Perform functional testing using computerized test equipment.
• Repair and rework components using microscopes and specialized tools when required.
• Complete production records, travelers, shop floor documentation, and quality documentation accurately.
• Maintain product traceability and ensure compliance with quality procedures.
• Follow all environmental health and safety guidelines, including proper hazardous waste disposal.
• Participate in continuous improvement and quality initiatives.
• Maintain a clean, organized, and safe work environment.
• Report equipment issues, production concerns, and material shortages to supervisors.

Required Qualifications:

• High school diploma or equivalent.
• Minimum of 2 years of manufacturing experience, preferably in medical device, electronics, or precision assembly.
• Ability to read, understand, and follow written English procedures.
• Basic math and measurement skills.
• Strong verbal communication skills in English.
• Experience using computers and electronic data collection systems.
• Excellent hand-eye coordination and manual dexterity for handling small components.
• Ability to prioritize tasks, work independently, and make sound decisions with minimal supervision.

Preferred Qualifications:

• Experience in medical device manufacturing.
• Cleanroom manufacturing experience.
• Experience with microscope assembly and inspection.
• Soldering and precision mechanical/electronic assembly experience.
• Knowledge of GMP, FDA, ISO, or regulated manufacturing environments.