Manufacturing Assembler

Position Summary

The Manufacturing Assembler position performs routine manufacturing operations for the production of commercial medical devices according to written specifications and manufacturing instructions.

Specific Job Functions

o Assemble medical devices in a controlled environment in accordance with detailed assembly instructions, processes and procedures.

• Excellent dexterity and fine motor skills to work on small parts and intricate assemblies, including the use of small hand tools.
• Ability to perform assembly work utilizing microscope or magnification.
• Confident in operating assembly equipment.

o Follow documented policies and procedures as designated by the company’s Quality System.

o Observe, maintain, coordinate and complete standard work.

o Perform in-process and final lot acceptance activities for product.

o Complete required documentation (batch records; equipment, inspection, and test forms; labeling forms) relating to business or regulatory requirements.

• Detail oriented ensuring all documentation is complete, legible, and accurate.

o Maintain a clean and organized work area to facilitate manufacturing functions.

o Complete quality work at acceptable department/ production determined rates.

o Work closely and communicate with other employees to build a cohesive production team within a dynamic, fast paced environment.

o Monitor, clean, and maintain the Controlled Environment Room(s).

o Communicate with supervisors/engineering on product performance, functionality issues and procedure updates.

o Understand and perform basic calculations.

o Competent working with computers and portable electronic devices.

Physical Requirements

o Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus. You may be required to provide verification of latest eye exam.

o Good vision.

o Good manual dexterity.

o Ability to sit for extended periods during the shift.

o Ability to lift up to 25 lbs.

Minimum Qualifications, Education & Work Experience

o High school diploma or equivalent is required.

o 2 years experience as a production assembler/operator in the medical device or pharmaceutical industry. Experience in other regulated industries may be acceptable.

o Ability to understand and execute established written procedures is essential.

o Good documentation and record keeping skills are essential.

o Experience working with ISO requirements, cGMP guidelines, and FDA regulations is a plus.

Job Type: Full-time

Pay: $16.00 - $20.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• High school or equivalent (Preferred)

Experience:

• Manufacturing: 2 years (Preferred)

Work Location: One location