Job Description

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.
  Other duties may be assigned.

Experience Required

• Experience working in a medical device manufacturing organization
• Experience testing and troubleshooting: laser based optical systems, fluidic systems, digital and analog circuitry

Skills & Certifications

Desirable Qualifications:

• 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

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

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