Production Operator I

Production Operator I

SetPoint Medical's Production Operator I is responsible for supporting safe, efficient, and high-quality manufacturing operations for the company's Class III medical device. This entry-level position performs routine manufacturing, assembly, packaging, and material handling activities while following established procedures and quality requirements. The role also supports inventory management, warehouse operations, and shipping and receiving activities as needed.

The ideal candidate is detail-oriented, eager to learn, and able to work effectively in a fast-paced, team-oriented environment. This position provides an opportunity to develop technical skills and gain experience in a regulated manufacturing setting.

Requirements

• Perform routine manufacturing, assembly, packaging, and labeling activities in accordance with approved procedures and work instructions.
• Operate basic production and test equipment under supervision.
• Conduct visual inspections and basic quality checks to verify products meet specifications.
• Complete production and inventory documentation accurately and in a timely manner.
• Follow GMP, GDP, safety requirements, and company procedures.
• Maintain cleanliness and organization of workstations, equipment, and production areas.
• Assist with material handling, inventory transactions, and product traceability activities.
• Support warehouse operations, inventory management, and shipping and receiving activities as needed.
• Assist with equipment setup and preparation for production activities.
• Report equipment, quality, or process issues to supervisors or designated personnel.
• Participate in training and continuous improvement activities.
• Collaborate with team members to meet production schedules and departmental objectives.

Qualifications

• High school diploma or equivalent.
• 02 years of experience in manufacturing, assembly, warehouse, or related environments.
• Basic computer and data entry skills.
• Basic mechanical aptitude.
• Experience in manufacturing, assembly, warehouse, or production environments is a plus.
• Experience in a regulated industry such as medical device, pharmaceutical, or biotechnology manufacturing is highly preferred.
• Familiarity with GMP, GDP, and quality system requirements is preferred.
• Experience using hand tools, measurement devices, or basic production equipment is strongly preferred.
• Knowledge of inventory control, material handling, and shipping and receiving processes is strongly preferred.
• Familiarity with ERP/MRP systems or electronic manufacturing records is highly preferred.
• Exposure to Lean Manufacturing or continuous improvement initiatives is a plus.

Skills & Abilities

• Ability to follow written and verbal instructions.
• Strong attention to detail and commitment to quality.
• Ability to work effectively in a team environment.
• Ability to learn new processes, procedures, and equipment operation.

Physical Requirements

• Ability to perform routine physical tasks, including lifting up to 35 pounds.
• Comfortable working in a standing position and performing repetitive tasks.
• Ability to use hands and fingers for assembly, packaging, and material handling activities.

Work Location and Travel

This position will report to our Company Headquarters in Valencia, CA. with minimal travel opportunities based on interest and business need.

Ability to work overtime as required to meet business needs.

Company Description

SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases.