Assembler – Metal Products Denver, CO · Contractor

Genesee Bio Medical, Inc. Assembler – Metal Products Denver, CO

The Assembler is responsible for the precision assembly of metal components used in medical devices, utilizing hand tools, microscopes, and specialized equipment in a controlled manufacturing environment while ensuring all work adheres to strict quality, safety, and regulatory standards.

A global leader, partner and resource for innovative medical devices and instrumentation. We design develop and manufacture unsurpassed quality products in the cardiac surgical space.

The Assembler is responsible for precision assembly of metal components used in medical devices, ensuring all work meets strict quality, safety, and regulatory standards. This role involves working with hand tools, microscopes, and other assembly equipment in a clean or controlled manufacturing environment.

• Assemble small and precision metal components according to work instructions, blueprints, and technical drawings.
• Operate hand tools, microscopes, pneumatic tools, and other assembly equipment.
• Perform visual and mechanical inspections during and after assembly.
• Ensure products meet required quality standards and document results as needed.
• Accurately complete device history records (DHRs) and other production documentation.
• Follow Good Manufacturing Practices (GMP), ISO 13485, and FDA guidelines.
• Maintain cleanliness and organization of workstations, including following cleanroom protocols if applicable.
• Collaborate with team members and supervisors to resolve issues and improve processes.
• Identify defective materials or non-conforming parts and report to quality control or supervisors.
• Participate in training and continuous improvement initiatives.

Qualifications

Education:

• High school diploma or equivalent required.

Experience:

• 1–2 years of experience in a manufacturing or assembly role, preferably in the medical device or regulated industry.

Skills and Abilities:

• Ability to read and interpret technical drawings, procedures, and work instructions.
• Experience working under a microscope or with small parts is highly desirable.
• Good hand-eye coordination and attention to detail.
• Ability to follow written and verbal instructions and work in a team-oriented environment.
• Basic computer skills for data entry and documentation.
• Knowledge of ISO 13485, GMP, and FDA regulations is a plus.

• Frequently sitting or standing at a workbench or assembly station.
• Manual dexterity and ability to handle small tools and parts.
• May require working in a cleanroom or controlled environment (gowning may be required).
• Occasional lifting of up to 25 lbs.
• Common PPE for Metal Finishing:
  Eye and Face Protection Safety goggles (for splash and dust protection), Face shields (especially when working with acids or grinding equipment), and respiratory Protection N95 or P100 respirators (for dust and particulates).