Operator / Manufacturing Technician/ Cleanroom Manufacturing Operator

Job Title: Manufacturing Operator I
Location: Braintree, Massachusetts
Job Type: Manufacturing / Medical Device ProductionJob Description:
We are seeking a detail-oriented Manufacturing Operator I to support medical device manufacturing operations in a regulated production environment. The ideal candidate will have cleanroom experience, basic mechanical and computer skills, and the ability to follow standard operating procedures (SOPs), maintain accurate manufacturing records, and comply with safety and quality requirements.

Important Requirement: Candidates must be comfortable handling cow hide/skin, which is used as biological material in the manufacturing process.

Key Responsibilities:

• Perform manufacturing and production operations according to established procedures and specifications.
• Work in a cleanroom environment while following full-body gowning requirements and contamination-control procedures.
• Handle cow hide/skin and other biological materials safely and according to company protocols.
• Operate manufacturing equipment and supporting tools as trained.
• Perform visual and dimensional inspections to verify product quality and specifications.
• Record production information, inspection results, training records, and other required documentation accurately.
• Follow Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and applicable quality standards.
• Handle chemicals safely and follow established health, safety, and environmental procedures.
• Maintain a clean, organized, and safe manufacturing work area.
• Complete all required safety, quality, and job-related training.
• Work effectively both independently and as part of a team.
• Use computers to enter production data and maintain manufacturing records.
• Follow company policies and applicable FDA, ISO, and other regulatory requirements.

Required Qualifications:

• High school diploma or GED.
• Previous cleanroom experience is required.
• Ability to read, write, and communicate effectively in English.
• Basic computer skills and experience entering production data.
• Basic mechanical skills and the ability to follow written procedures.
• Knowledge of chemical handling and workplace safety practices.
• Ability to work with cow hide/skin and biological materials.
• Ability to follow cleanroom gowning, hygiene, and contamination-control requirements.
• Strong attention to detail and commitment to product quality.
• Ability to work in a team-oriented manufacturing environment.
• Ability to stand and/or walk for more than 80% of the workday.
• Ability to lift up to 25 pounds and perform repetitive manufacturing tasks.

Preferred Qualifications:

• 0 3 years of experience in manufacturing, production, operations, or a related field.
• Experience in medical device, pharmaceutical, or other regulated manufacturing environments.
• Familiarity with GMP, SOPs, FDA, or ISO quality requirements.
• Experience operating manufacturing equipment or computer-controlled machinery.
• Knowledge of basic measurement tools, inspection procedures, and quality documentation.
• Experience with precision machining or equipment such as lathes, grinders, honing machines, and automated washers is a plus