Assembly Technician

JOB OVERVIEW:

The Assembly Technician is a key role focused on the precise assembly, testing, and inspection of medical devices to ensure they meet stringent quality standards. This position involves hands-on tasks such as assembling components, conducting functional testing, and maintaining accurate production records. The technician will work closely with the operations team, adhering to detailed instructions and protocols to ensure product integrity and safety. This role requires a strong attention to detail, manual dexterity, and a commitment to quality control. The Assembly Technician reports directly to the Director of Operations.

JOB RESPONSIBILITIES AND DUTIES:

• Consistently models the core values of the company both internally and externally.
• Openly commit to and support company processes and systems.
• Understand and follow the processes of the Rampart Quality System
• Assemble medical device components and products according to detailed instructions, blueprints, and standard operating procedures [SOPs). Ensure all assembled products meet quality and safety standards.
• Perform quality control checks and inspections on assembled products. Identify and report any defects or issues, ensuring only high-quality products are released.
• Conduct functional testing of assembled devices to verify proper operation. Accurately record and document test results.
• Operate assembly equipment and tools safely and efficiently. Perform routine maintenance and troubleshooting of assembly machinery as needed.
• Maintain accurate and detailed production and assembly records. Complete required documentation for each assembled unit, ensuring traceability and compliance.
• Occasionally travel to customer sites for on-site assembly.
• Adhere to all company policies, safety regulations, and industry standards. Follow Good Manufacturing Practices [GMP) and ISO standards.
• Work closely with engineering, quality assurance, and other departments to resolve issues and improve assembly processes. Participate in team meetings and training sessions to stay updated on best practices and new procedures.
• Identify opportunities for process improvements and contribute to the development and implementation of more efficient assembly techniques. Suggest enhancements to improve product quality and assembly efficiency.
• Maintain up to date vaccination status for COVID-19, flu, and tuberculosis.
• Any other duty as required by supervisor.

KEY METRICS:

• First Pass Yield [FPY]: Tracks the percentage of products that pass quality inspection without needing rework, indicating the accuracy and effectiveness of the assembly process.
• Defect Rate: Monitors the number of defective units produced, aiming to minimize errors and improve overall quality.
• Cycle Time: Assesses the average time taken to assemble a single unit, helping to identify bottlenecks and opportunities for process optimization.
• Compliance with Standard Operating Procedures [SOPs]: Evaluates adherence to SOPs and protocols, ensuring consistency and regulatory compliance in the assembly process.

QUALIFICATIONS/EDUCATION AND EXPERIENCE:

• Attention to Detail: Strong focus on accuracy and prec1s1on in assembling small and intricate components.
• Manual Dexterity: Proficiency in handling tools and delicate parts, with steady hand-eye coordination.
• Technical Skills: Ability to read and interpret blueprints, diagrams, and standard operating procedures [SOPs).
• Problem-Solving: Capability to troubleshoot and resolve assembly issues efficiently.
• Communication: Good verbal and written communication skills to document processes and collaborate with team members.
• Teamwork: Ability to work effectively in a team environment and contribute to continuous improvement efforts.
• Basic Computer Skills: Proficiency in using basic computer applications for documentation and record-keeping.
• Education: High school diploma or equivalent required. Technical or vocational training in assembly or manufacturing is a plus.
• Experience: Previous experience in medical device assembly, manufacturing, or a related field preferred.

PHYSICAL ACTIVITIES:

The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this position.

• Body Positions: Regularly required sitting, standing, and walking for pro-longed periods of time.
• Body Movements: Full range of body movements including the use of hands and fingers, to handle or feel objects, including computer equipment and peripherals, and bending, reaching, lifting, and crouching.
• Vision: Ability to read and see instructions, computer screens, and small parts for assembly.

MENTAL REQUIREMENTS:

• Attention to Detail: Must be able to focus on small details and ensure accuracy and precision in the assembly of components.
• Relational: Must be able to comfortably connect and work with different personalities both inside and outside the company.
• Communication Skills: Must be able to read and write clearly to effectively communicate with team members and supervisors.

WORKING CONDITIONS

• Environment: Work is performed in a typical assembly shop environment. The area is usually well-lit and ventilated but may involve exposure to moderate noise levels from machinery and equipment.
• Physical Demands: The role involves standing, sitting, and performing repetitive tasks for extended periods. Manual dexterity is required for handling small components and tools. Lifting and moving objects up to 50 lb.
• Work Hours: Full-time position with standard working hours, typically Monday through Friday.
• Occasional overtime or weekend work may be required to meet production deadlines.
• Protective Gear: Use of personal protective equipment (PPE) such as safety glasses, gloves, and ear protection is mandatory to ensure safety.
• Temperature: The temperature in the assembly shop may vary but is typically maintained at a comfortable level. Occasional exposure to cooler or warmer conditions may occur depending on the season and ventilation.
• Health and Safety: Strict adherence to health and safety guidelines is required to prevent accidents and ensure a safe working environment for all employees. Regular training on safety procedures and emergency protocols is provided.