Job Description
Job Description
The Medical Assembler supports manufacturing operations by assembling, packaging, and performing secondary operations on medical devices in compliance with ISO 13485, ISO 9001, FDA regulations, and Good Manufacturing Practices (GMP). This role is critical to ensuring high-quality products are manufactured safely, accurately, and efficiently in a regulated medical device environment.
Aptyx is seeking dependable, detail-oriented individuals who thrive in a fast-paced manufacturing setting and are committed to quality, teamwork, and continuous improvement.
Essential Duties and Responsibilities
- Perform assembly, packaging, and secondary manufacturing operations as assigned.
- Follow all GMP, FDA, ISO, environmental, and company quality system requirements.
- Adhere to established safety policies and procedures at all times.
- Accurately follow work instructions, travelers, and quality documentation for assigned job orders.
- Conduct in-process inspections to ensure only conforming products are produced and released.
- Maintain required production output while meeting quality standards.
- Accurately record and report individual production output and issues to the Floor Manager.
- Utilize hand tools, fixtures, and manufacturing equipment as required.
- Work effectively both independently and as part of a team.
- Maintain cleanliness and organization of the work area, including cleanroom environments when applicable.
- Demonstrate flexibility and willingness to learn new processes in a changing manufacturing environment.
Required Qualifications
- High School diploma or equivalent.
- Ability to read, write, and understand English.
- Ability to understand and follow written and verbal work instructions, process guidelines, and quality documentation.
- Basic mathematical aptitude.
- Ability to work productively with indirect supervision.
- Reliable transportation.
Preferred Qualifications
- Prior experience in medical device manufacturing or other regulated manufacturing environments.
- Experience working in a cleanroom environment.
- Ability to read and interpret technical drawings and blueprints.
Physical Demands
- Ability to perform delicate, repetitive tasks involving small components.
- Ability to sit or stand for extended periods based on job assignment.
- Ability to lift and move materials weighing up to 25 pounds.
- Manual dexterity and visual acuity sufficient to perform detailed assembly and inspection work.
Work Environment
- Manufacturing and cleanroom environments with exposure to controlled conditions.
- Use of personal protective equipment (PPE) as required.
- Normal manufacturing noise levels.