Instrument Assembler - Exp in Medical Device Industry

Job Description

Performs electro-mechanical assembly of flow cytometers, sub-assemblies, and related medical device products. Follows established methods and procedures in performing, assembly of optical, mechanical, fluidic, and electronic components and assemblies.

Employs high standards of workmanship to ensure high quality products are produced on schedule. Efficiently works on assignments that are routine.

Understands implications of work and makes recommendations for improvement. Normally receives some instruction on daily work, uses independent judgment for some activities and employs a moderate degree of initiative.

Duties and Responsibilities

• Performs instrument assembly by following released procedures.
• Performs in process inspection to ensure products meet specifications and standards.
• Generates required documentation to complete the Device History Record (DHR).
• May require engineering support to resolve complex and unique problems.
• 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.
• May support new product introductions; determines, develops, and documents optimal assembly methods.
• Expected to provide feedback on production and methods, product design issues, continuously strives to improve product quality and operational efficiency.
• Will provide support to project teams whose objectives may be quality improvement, cost reduction, cycle time reduction, reliability improvement, increase operational efficiency, or new product introduction.
• Assists in creating and updating process and product documentation.
• 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.
• Collects and documents key measurements and data. Reviews metrics on a regular basis and strives to improve individual and group performance.
• Keep work area clean organized and safe.
• Fills out time sheets and all other required paperwork accurately and on time. Keeps training file up to date at all times.

Minimum Qualifications

• 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, Windows and/or MAC OS
• Knowledge and adherence to safety procedures and programs
• Exposure to ISO 9000 and cGMP 21 CFR part 820
• Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)

Education and Experience

• 2+ years related experience in a high tech, manufacturing environment
• High School diploma or equivalent A.S. degree, or vocational instruction in electro-mechanical assembly
• Experience working in a medical device manufacturing organization
• Experience building: laser based optical systems, fluidic systems, digital and analog circuitry