Assembly Technician

The Production Assembler Technician is responsible for the assembly, testing, and inspection of medical devices within a regulated manufacturing environment.

This position involves assembling components to specifications, conducting thorough testing, and ensuring all products meet rigorous quality standards and regulatory guidelines before they are released for distribution. The ideal candidate will be detail-oriented, skilled in using assembly tools, and knowledgeable about quality control practices, contributing to the delivery of safe and reliable medical devices.

Essential Duties and Responsibilities

· Assemble of mechanical and Electromechanical components and sub-assemblies into final medical devices according to required work instructions

· Utilize hand tools, and specialized testing equipment to assemble devices.

· Perform visual inspections and functional checks during assembly to ensure quality and conformance to specifications.

· Conduct functional testing and inspections on finished products

· Use specialized testing equipment to assess product performance and functionality.

· Document test results, identify defects, and work with the production team to resolve any issues.

· Follow standard operating procedures (SOPs) and comply with Good Manufacturing Practices (GMP).

· Maintain cleanliness and organization of the work area to prevent contamination of products.

· Perform in-process inspections and contribute to the identification and correction of any deviations from quality standards.

· Work closely with production, engineering, and quality assurance teams to resolve issues and improve processes.

· Support production scheduling to meet deadlines and production goals.

· Record assembly, testing, and inspection data accurately, ensuring compliance with company standards and regulatory requirements.

· Maintain and update records of assembly and testing procedures.

Minimum Qualifications Knowledge, Skills, and Abilities

· Familiarity with assembly processes, including wiring and harness assembly, and mechanical assembly techniques.

· Understanding of medical device regulations (e.g., FDA, ISO 13485) and compliance standards.

· Ability to read and interpret mechanical drawings, schematics, and assembly instructions.

· Good manual dexterity and hand-eye coordination.

· Comfortable working with electronic components and small-scale assembly.

· Good computer Skiles Office and windows, and understanding the use of specific SW like Analog devises programing

· Ability to work in a fast-paced environment and meet production deadlines.

· Good communication skills, both written and verbal, for documentation and collaboration.

· Team-oriented with a proactive approach to supporting coworkers and meeting goals.

· Ability to lift and move small parts or tools, typically up to 11 Kg

Education& Experience

*High School Diploma or equivalent required.

*Associate's degree in manufacturing, or practical mechanical Engineering, or electronics, or a related field is a plus.

*Minimum of 3-4 years of experience in a production or assembly role, preferably in a medical device or regulated industry.

*Experience with final testing and quality control processes for medical devices and multidisciplinary products

*ERP experience -Mandatory. Preferred – Priority ERP.

*IPC Certification - an advantage

*Lean manufacturing or Six Sigma certification- an advantage