Assembly / Operator
Aptyx
Job Description
Job Description
Job Description
Production Operator – Stethoscope Manufacturing
Position Summary
The Production Operator is responsible for manufacturing, assembling, inspecting, testing, and packaging medical device products, including stethoscopes, in accordance with Solventum quality standards, regulatory requirements, and established work instructions. This position ensures products meet customer specifications while maintaining a safe, efficient, and compliant manufacturing environment.
Essential Duties and Responsibilities
- Assemble stethoscope components according to standardized work instructions.
- Operate manual, semi-automated, and automated production equipment.
- Perform visual and functional inspections to ensure product quality and compliance with specifications.
- Conduct in-process quality checks and accurately document production and inspection results.
- Read and follow manufacturing procedures, drawings, work instructions, and standard operating procedures (SOPs).
- Identify and report product defects, equipment issues, or process deviations to the appropriate supervisor.
- Perform basic equipment setup, cleaning, and preventive maintenance as required.
- Package finished products according to customer and regulatory requirements.
- Maintain accurate production records in paper and/or electronic manufacturing systems.
- Follow Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO 13485 requirements, FDA Quality System Regulations (21 CFR Part 820), and all company quality procedures.
- Maintain a clean and organized work area using 5S and Lean Manufacturing principles.
- Comply with all Environmental, Health & Safety (EHS) policies and wear required personal protective equipment (PPE).
- Participate in continuous improvement initiatives to improve safety, quality, delivery, and productivity.
- Cross-train in multiple production areas to support operational needs.
- Perform other duties as assigned.
Qualifications
- High school diploma or GED required.
- Previous manufacturing, assembly, or medical device production experience preferred.
- Ability to read and follow written work instructions and production documentation.
- Basic computer and data entry skills.
- Strong attention to detail and commitment to producing high-quality products.
- Ability to work independently and as part of a team.
Physical Requirements
- Ability to sit or stand for extended periods.
- Frequent use of hands and fingers to assemble small components.
- Good manual dexterity and hand-eye coordination.
- Ability to distinguish colors and perform detailed visual inspections.
- Ability to lift up to 25 pounds occasionally.
- Ability to perform repetitive motions throughout the work shift.
Work Environment
- Climate-controlled medical device manufacturing environment.
- May require the use of safety glasses, gloves, hearing protection, and other PPE as applicable.
- Regular attendance and schedule flexibility, including overtime, may be required to meet production demands.
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