Assembler III

The role of the Assembly Technician III is to perform and ensure production assembly tasks are actively completed to meet production schedules while upholding the highest level of quality. The assembler will assemble products by using a variety of hand and power tools, soldering irons, fixtures, work instructions and various other equipment to perform a series of operations to correctly assemble medical devices. The Assembly Technician III should have excellent communication skills and be able to coach, train, and lead other assemblers and troubleshoot mechanical and electrical assemblies. The Assembly Technician III is expected to be able to work in a team environment as well as working with very limited supervision.

Duties/Responsibilities:

• Understand, support, and comply with the Company Quality System requirements.
• Maintain a safe and clean work environment.
• Follow the standard operating procedures and written work instructions.
• Openly communicate with the Company team members.
• Work with Supervisor and lead other production assemblers to produce customer products while ensuring that Quality, production requirements and goals are achieved.
• Complete required documentation relating to business or regulatory requirements.
• Perform chassis and final build level of product assembly.
• Understand blueprints and or assembly instructions as well as hardware call out requirements.
• Ability to perform soldering tasks.
• Report problems or concerns with quality, processes, equipment, materials, and labor.
• Identify and support continuous improvement efforts with Production Supervisor.
• Take on special projects as assigned.
• Testing finished products for defects.
• Wiring of electronics and complex assemblies and panels.
• Other duties as assigned.

Required Skills/Abilities:

• Ability to read and interpret documents such as blueprints, work instructions and procedure manuals.
• Ability to follow wire run diagrams for electro-mechanical system wiring.
• Strong mechanical and electrical aptitude abilities.
• Use of manual and electronic torque tools, and other wrenches and tools.
• Use of wire cutters, crimping tools, and soldering.
• PCBA handling, integration, and connectivity.
• Ability to understand and follow proper ESD practices.
• Assembly of pneumatic and fluidic systems including pumps, tubing, and various interconnects.
• Inspection tools such as vernier calipers and digital height gauges.
• Mechanical and electrical troubleshooting of assemblies.
• Use of microscopes for small assembly beneficial.
• Use of part cleaning technologies such as ultrasonic cleaning.
• Ability to communicate effectively through oral and written communications.
• Ability to work with others collaboratively.
• Attention to detail to understand and meet the requirements.
• Strong organizational skills.
• Demonstrated problem solving ability in a cross functional environment.
• Take responsibility for task and time management.

Education and Experience:

• 7+ years in a regulated manufacturing environment, experience in an ISO 13485:2016, FDA Quality System Regulation (21 CFR 820) compliant manufacturing environment is preferred.
• Understanding of GDP and GMP, Good Documentation Practices and Good Manufacturing Practices.
• Team leadership experience.
• Training experience.
• Cleanroom assembly experience beneficial, preferably ISO Class 7.
• Experience with working to time standards.
• High School graduate.

Physical Requirements:

• Full range of motion for wrist, hand, and finger dexterity.
• Ability to frequently sit, stand, walk, stoop, kneel, and crouch.
• Ability to regularly lift/push/carry on average 30 pounds and at times up to 45 pounds.
• Ability to see up close and from a distance for assembly and evaluation.

On-Site/Remote Attendance:

This position requires 100% on-site attendance.