Job Title: Assembler

Duration: 3 Months Contract

Location: Mansfield, MA 02048

Shift: First shift, hours 7 am 3:30 pm Monday Friday.

Pay Rate: $20.00/ hour

Job Description

This position is responsible for the assembly, packaging, and other steps along the production line of

various medical devices as required by clients. Adherence to Good Manufacturing Practices (GMP) and

FDA, ISO, and environmental requirements.

This position must adhere to safety guidelines and standards to ensure the products are properly

assembled and packaged. This role helps move a product towards the consumer market.

Key Responsibilities:

Accountable for the day-to-day manufacturing activities, which include but are not limited to:

  • Work on the required manufacturing shop orders/workload
  • Maintain appropriate training as required by the company
  • Production accuracy and quality
  • Accurately follow manufacturing procedures and quality standards
  • Ensure that the proper material is available to perform the assigned manufacturing work
  • As required, work with Engineering personnel to assist and develop process and equipment validation/qualification plans and protocols
  • Assist/support in the execution of such plans, which include testing, data collection, etc.
    • Provide problem solving support to the manufacturing operation as required
    • Work closely with and play an integral role in the team building process with other cross-functional groups including, but not limited to, Quality Department and Development
    • Other responsibilities as required

Minimum Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

The requirements that follow are representative of the knowledge, skills, and/or abilities required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential

functions. Once initially qualified, the employee's continuing competency is appraised during the

introductory period. Long-term competency is evaluated by the supervisor, using work quality and

continuous training as deemed necessary.

LANGUAGE SKILLS:

Ability to read and write in English. Ability to read and interpret documents such as safety rules,

manufacturing work instructions and procedures, operating instructions, engineering drawings, and

procedure manuals. Good communication skills to interact with coworkers.

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide. Ability to read production sheets, graphs, and understand

their practical application. Must be able to add and subtract decimals. Must be able to set-up gages that

are used for measuring parts and adjusting machines.

REASONING ABILITY

Ability to apply basic reasoning skills. Ability to understand carrying out instructions furnished in written,

oral, or diagram form. Ability to detect and identify typical defects found in materials. Ability to deal with

problems involving several concrete variables in standardized situations. Ability to read and use various

equipment applications and tools, and understand and apply basic inspection and sound measurement

practices. Basic knowledge of Level 3 principles.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential functions of this job. Reasonable accommodations may be made to

enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is constantly required to stand. The employee is

frequently required to walk; reach with hands/arms; and use hands to finger, handle, feel and/or finely

manipulate objects. The employee is occasionally required to lift and/or lower, carry, push and/or pull,

step, rotate head/neck or maintain a static head/neck position, crouch/squat, sit, bend, talk, and hear. The

employee must constantly lift and/or move up to 20 lbs. and occasionally lift and/or move up to 50 lbs.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral

vision, depth perception, and ability to adjust focus. Use of vision correction is acceptable, if necessary;

however, any vision correction apparatus must meet all safety guidelines for the area of activity.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters

while performing the essential functions of this job. Reasonable accommodations may be made to enable

individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts.

The employee is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, and

temperature extremes. The employee is occasionally exposed to toxic or caustic chemicals. The noise level

in the work environment is usually loud.

EDUCATION and/or EXPERIENCE

Required:

High School diploma, or equivalent

Desired:

    • Minimum of one (1) years' experience in manufacturing operations with medical devices.
    • Knowledge and experience with GMP, ISO, FDA, and quality standards
    • Experience with manufacturing documentation such as, but not limited to, Bill of Materials (BOM), shop orders, routers, and other relevant manufacturing documentation including the maintenance of manufacturing metrics.
    • Experience in a Clean Room environment

Skills/Competencies:

  • Read, write, and understand English
  • Ability to understand documentation such as, but not limited to, Bill of Materials (BOM), shop orders, routers, and other relevant manufacturing documentation including the maintenance of manufacturing metrics.
  • Ability to remain productive under indirect supervision and follow verbal and written instructions and techniques Ability to lift up 20 lbs.
  • Basic mathematical aptitude required

CERTIFICATION/TRAINING REQUIRED

Ongoing job-specific training will be required throughout the duration of employment for necessary skills

such as specific training, quality requirements and procedures, etc.


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