Assembler

Job Description

Job Description

Job Title: Assembler

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

SUMMARY:

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.

ESSENTIAL DUTIES AND KEY RESPONSIBILITIES:

• Accountable for the day-to-day manufacturing activities, which include but are not limited to: o Work on the required manufacturing shop orders/work load

o Maintain appropriate training as required by the company

o Production accuracy and quality

o Accurately follow manufacturing procedures and quality standards

o 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 o 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

SUPERVISORY RESPONSIBILITIES:

This role does not have supervisory responsibilities.

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.