Operator ILocation: Portland, OR 97224
Schedule: Monday Thursday, 4:00 AM 2:30 PMJob Summary: We are seeking a detail-oriented
Operator I to support the production of high-quality medical devices within a manufacturing cell. Under close supervision, the Operator I will perform routine
assembly, repair, and testing operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies.
The ideal candidate will be comfortable working with small components, following standardized procedures, maintaining accurate production documentation, and working in a quality-focused medical device manufacturing environment.
Key Responsibilities:- Perform routine assembly, repair, and testing operations on medical device products and components.
- Work with pacemakers, ICDs, leads, and related medical device assemblies according to established procedures.
- Follow written work instructions, standard operating procedures, and verbal instructions accurately.
- Handle and maneuver small components and precision parts with care and attention to detail.
- Maintain accurate and up-to-date manufacturing and job documentation.
- Complete travelers, quality records, production records, and other required documentation.
- Ensure all parts and components are properly identified and traceable throughout the manufacturing process.
- Perform quality checks and identify potential quality issues during production.
- Utilize electronic data collection systems and computer software to record production information.
- Communicate manufacturing issues, ideas, and potential solutions clearly to supervisors and manufacturing management.
- Participate in continuous improvement and quality initiatives to improve production processes, quality, and profitability.
- Demonstrate a basic understanding of Lean Manufacturing principles.
- Support manufacturing supervisors and managers in monitoring individual goals and cell performance metrics.
- Follow all applicable safety procedures, quality requirements, and regulatory standards.
- Properly use required safety equipment and devices during manufacturing operations.
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other divisional initiatives.
- Maintain a positive and professional attitude when interacting with coworkers, management, internal customers, and external visitors.
- Prioritize work based on job requirements, precedence, and production needs.
- Make appropriate decisions and judgments while performing assigned tasks.
- Maintain a clean, organized, and compliant production work area.
- Perform other duties as assigned.
Required Qualifications:- High school diploma or equivalent preferred.
- Ability to read, comprehend, and follow written procedures and work instructions.
- Ability to understand and follow verbal instructions.
- Basic computer skills and ability to use electronic data collection systems.
- Ability to work with small components and parts requiring precision handling.
- Strong attention to detail and commitment to product quality.
- Ability to maintain accurate production and quality documentation.
- Ability to prioritize and sequence work based on production requirements.
- Strong verbal and written communication skills.
- Ability to work effectively in a team-oriented manufacturing environment.
- Ability to make sound decisions and judgments with minimal supervision.
- Ability to follow safety, quality, and regulatory requirements.
Preferred Qualifications:- Previous experience in medical device manufacturing.
- Experience with assembly, testing, repair, or production operations.
- Experience working with pacemakers, ICDs, leads, or other medical devices.
- Manufacturing or cleanroom experience.
- Familiarity with Lean Manufacturing and continuous improvement.
- Experience with Quality Management Systems (QMS).
- Experience with manufacturing documentation, travelers, and product traceability.