Instrument Test Associate II

Roles & Responsibilities

Essential Functions:

• Performs instrument optimization functions after final assembly: laser alignment, pressure adjustments, electrical adjustments, etc.
• Performs final production testing and inspection to ensure products meet performance specifications and standards.
• Analyzes test results on defective units to determine root cause of failure.
• Replaces or repairs defective components or assemblies, processes appropriate paperwork, may return unit to assembly for repair.
• Compares test results with specifications and records test data and plots test results. Generates required documentation to complete the Device History Record (DHR)
• Analyzes test results on defective units to determine root cause of failure.
• Frequently requires engineering support to resolve complex and unique problems.
• Must be able to read and understand: detailed test instructions, assembly instructions, work orders, test results, 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 testing procedures and results and to resolve problems.
• Determines, develops and documents troubleshooting techniques.
• Expected to provide feedback on production and test 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
• Fill out time sheets and all other required paperwork accurately and on time.
• Keeps training file up to date at all times.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements.
• Participates as required in training on regulatory issues affecting own area of work.
• Brings regulatory compliance questions/issues to the attention of management.
• Follows BDIS Environmental, Health and Safety (EH&S) policies and procedures.
• Takes responsibility for safety in immediate work area.
• Participates in EH&S programs.
• Notifies supervisors of all observed hazardous conditions or unsafe work practices.
• May provide recommendations on maintaining the safety of the work environment

Experience Required

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

Skills & Certifications

Desirable Qualifications:

• Experience working in a medical device manufacturing organization
• Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry
• Extensive knowledge of PC’s and networking environments
• Strong experience with Excel, Visio, Power Point
• Strong knowledge of ISO 9000 and cGMP 21 CFR part 820
• Knowledge of LEAN Manufacturing, Six Sigma tools and concepts, Demand Flow Technology (DFT)
• Strong experience with Logic Analyzer and Oscilloscope

Eligibilities & qualifications

Other duties may be assigned

Minimum Requirements:

• Requires an Associate's degree (A.S.) or equivalent from two-year college or technical school
• 3+ years related experience in a high tech, manufacturing environment
• Ability to effectively communicate information and respond to questions both verbally and in writing.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Good mechanical aptitude, dexterity and hand/eye coordination. Must be able to reach, bend and lift 35 lbs on a daily basis
• Experienced in the use of: DVM’s, Oscilloscope and general test equipment,
• Experienced PC or MAC user, familiar with: Word, Excel, Windows and/or MAC OS
• 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
• Exposure to ISO 9000 and cGMP 21 CFR part 820