Assembler 2, Instrument

Responsibilities:

Performs instrument assembly by following released procedures.

Must be able to read and understand assembly instructions, work orders, Bills of Materials, Standard Operation Procedures, and all other documentation used to control our products and processes.

Confers with engineers, technicians, production personnel, and others regarding assembly procedures.

Must have the ability to create and maintain productive working relationships within the work team and with other functions.

Collaborates with peers to achieve shared departmental goals.

Keep work area clean organized and safe.

Fill out time sheets and all other required paperwork accurately and on time.

Keeps training file up to date at all times.

Ability to effectively communicate information and respond to questions both verbally and in writing.

Good mechanical aptitude, dexterity and hand/eye coordination.

Must be able to reach, bend and lift 35 lbs. on a daily basis.

PC or MAC user, familiar with: Word, Excel, and Windows.

Must be willing to be trained in other areas of production where the skill level requirements may be lower.

Knowledge and adherence to safety procedures and programs

Occasionally, this position will also require assisting packaging base on business needs.

Responsible for the manual inspection, labeling, and packaging of clinical and commercial products.

Perform finished product packaging as required to satisfy all customer, internal, clinical, and other demand.

Ensure finished product is packaged in accordance with procedures and Quality specifications.

Inspect in-process packaging, components to ensure consistent quality and remove defective products and packaging material.

Perform routine cleaning of packaging station and processing equipment.

Abide by all personal protective equipment and product contamination control (i.e., gowning) requirements.

Handle hazardous waste as appropriate. Work well in a team environment.

Good documentation practices.

Must be willing and able to work a flexible work schedule including static or rotating shifts and overtime as required. Requirements:

Requires a High school or GED degree.

Ability to effectively communicate information and respond to questions both verbally and in writing.

Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs. on a daily basis.

Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS

Knowledge of PC's and networking environments

Must be able to follow established methods and procedures in performing ex: assembly of optical, mechanical, fluidic and/or electronic components, assemblies, and testing.

Experience working in a medical device manufacturing organization.

3+ years related experience in a high tech, manufacturing environment.

Experience with Excel, Visio, Power Point

Knowledge of ISO 9000, cGMP 21 CFR part 820 or FDA

Performs electro-mechanical assembly and sub-assemblies for medical device products.

SAP experience preferred.