Quality Electronics Technician II

The Quality Electronics Technician II will perform and ensure the quality production and service activities are completed to meet the customer delivery schedules while upholding the highest possible level of Quality. The Quality Electronics Technician II will inspect, test, and troubleshoot the medical device products using assembly fixtures, work instructions, procedures and other equipment or documentation to ensure the product specification compliance.

Job Summary and Objectives:

The Quality Electronics Technician II will perform and ensure the quality production and service activities are completed to meet the customer delivery schedules while upholding the highest possible level of Quality. The Quality Electronics Technician II will inspect, test, and troubleshoot the medical device products using assembly fixtures, work instructions, procedures and other equipment or documentation to ensure the product specification compliance. The Quality Electronics Technician is required to follow Good Documentation Practices and work in compliance with our quality management system that is based on ISO 13485 and 21 CFR 820. The Quality Electronics Technician is expected to always be an advocate for our Quality Policy and Core Values.

Essential Duties and 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, Lead assembler and 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.
• Capability to perform production tasks of, wire crimping, and minor sub assembly fabrication.
• 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.
• Perform such other functions, responsibilities, tasks and/or projects that are reasonably related to the above essential job functions and responsibilities and/or as NextPhase Medical Devices LLC may from time-to-time assign to the employee.

Supervisory Responsibilities:

• Does not regularly supervise employees.

Required Qualifications and Work Experience:

• Minimum Education and Experience:

• 2-5 years in a regulated manufacturing environment, experience in an ISO 13485 manufacturing environment is preferred.
• Certificate or Associates in an applicable field of study or relevant experience is preferred.

• Skills/Abilities

• Assembly, inspecting, testing, verifying, troubleshooting, and repairing environment.
• Related PCBA and electro-mechanical experience, or equivalent combination of education and experience.
• Ability to read and interpret documents such as mechanical drawings, part drawings, schematic diagrams, work instructions, bill of materials and procedure manuals.
• Familiar with test equipment including but not limited to oscilloscope, frequency generator, power supplies, multi-meters, flow meter, pull tester and microscope.
• Strong mechanical and electrical aptitude abilities.
• 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.
• Strong verbal communication skills.
• Demonstrated problem solving ability in a cross functional environment.
• Take responsibility for task and time management.
• Experience with working to time standards.

Physical Demands:

• 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 use a microscope and/or magnifier lamp for visual inspection and evaluation.
• Ability to see up close and from a distance for visual inspection and evaluation.