Assembler 2

PURPOSE OF JOB:

Assemblers performs assembly, inspection, and test steps to manufacture complex catheter based medical devices per documented procedure in a timely manner.

RESPONSIBILITIES:

• Uses hand tools, fixtures and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)

• Accurately documents record of work on Lot History Record (LHR) and manufacturing forms

• Sets up and maintains workstation; adheres to CER (Controlled Environment Room) requirements

• Operates production equipment such as hot box, laminator and coil winder

• Performs visual inspection and uses basic measuring tools such as caliper and snap gage

• Identifies units that are non-conforming and notifies management

• Provides feedback to management and engineers regarding process and product improvements

• Relies on experience and judgement to plan and accomplish goals [Assembler 4]

• Self-directed, independently manages time and takes initiative to solve problems [Assembler 4]

• Other duties as assigned; available to work overtime as requested

REQUIRED EDUCATION AND SKILLS:

• High school diploma or equivalent

• Ability to read and speak English (i.e., read and understand manufacturing procedures)

• Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements

• Effective communication, interpersonal and team skills

• Able work with minimal supervision and without instruction on routine work. [Assembler 4]

• Excellent attention to detail and organization [Assembler 4]

PREFERRED EXPERIENCE:

• Minimum 3 years of experience in medical device manufacturing, catheter based preferred [Assembler 2]

• Minimum 5 years of experience in medical device manufacturing, catheter based preferred [Assembler 3]

• Minimum of 10 years of experience in medical device manufacturing, catheter experience a must [Assembler 4]

• Understanding of commonly used concepts, practices and procedures within the medical device industry, especially catheter based

• Ability to use microscopes, tweezers, razor blades, pliers and other handheld tools for small parts.

• Proficiency with use of equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer