Manufactoring Technician-Medical Device

SUMMARY

Repairs and maintains machinery and mechanical equipment such as machines, motors, pneumatic tools, conveyor systems, and production machines and equipment by performing the following duties. Lays out, builds, tests, troubleshoots, repairs and modifies developmental and production electronic components, parts, equipment, and systems

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Provides feedback and pro-active communication to supervisors, management and coworkers to ensure efficient operations. Contributions are based on industry experience and hands-on knowledge of mechanical and/or electrical systems, and components.
  • Troubleshoots and solves problems with routine manufacturing processes and equipment, documenting activities according to GMP and other regulatory requirements. Works to keep equipment and operations running efficiently and to the quality standards of the company.
  • Assists manufacturing engineering and project engineering in identifying, specifying, and ensuring new equipment specifically custom automation equipment, conforms to internal requirements, limitations and specifications for service utilities, software, mechanical or other attributes. Participate in project planning meetings and design reviews, and recommend possible solutions.   Assists in the design, build and development of prototypes for evaluation by engineering and marketing.
  • Interfaces with manufacturing, engineering, project engineering, toolmakers and outside services to design, install, repair, program, retrofit, interface and upgrade electro-mechanical machinery.
  • Assists manufacturing and project engineering with creation and execution of process validation activities.
  • Studies production processes and makes recommendations for improvements or changes to standards and manufacturing procedure specifications that will improve overall production methods, equipment performance, and quality of product.
  • Enforces and contributes to a culture of safety and GMP compliance through technical specifications, training, and awareness of standards and regulations. Follows the official policy for Good Manufacturing Practices as required in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act and adheres to all company policies, rules, procedures and housekeeping standards.
  • Assists manufacturing in inspecting shop equipment, new or repaired equipment and product for form, texture, defects or imperfections and makes necessary changes to bring product into specification.  Performs initial setups on equipment to ensure a high level of performance and quality of product being manufacturing on that equipment.
  • Performs preventive maintenance on various equipment following documented procedures.  This may include disassembly, adjusting, altering, calibrating,  lubrication, cleaning repairing and/or replacement of defective components.
  • Interfaces with suppliers and initiates purchase orders for parts and machines using the 5S systems already in place or whenever a repair defines a replacement component is required.  This may involve research to define an equivalent replacement device.
  • Performs daily routine troubleshooting that may involve diagnosing malfunctioning apparatus such as transformers, motors, and lighting fixtures and replaces damaged or broken wires and cables.
  • Diagnoses and either repairs or replaces faulty electrical components of machines such as relays, switches, circuit boards, motors, bearings or sensing devices. This extends to other mechanical devices, hydraulics and pneumatics on the equipment.
  • Plans layout of wiring and installs wiring, conduit, and electrical apparatus in buildings.
  • Assist in conducting training sessions with new employee orientation, and on-the-job training as required.
  • Sets up standard test apparatus or devises test equipment and circuitry to conduct functional, operational, environmental, and life tests to evaluate performance and reliability of prototype or production model.
  • Writes technical reports, procedures and develops charts, graphs, and schematics to describe and illustrate system's operating characteristics, malfunctions, deviations from design specifications, and functional limitations.
  • Experience with various TQ tools to analyze trends through statistical analysis. Quality control measurement ability using calipers/micrometers and other inspection equipment.  Works within tolerances  as close as +/-.0001
  • Provide other department and manufacturing support as requested by immediate supervisor.

EDUCATION and/or EXPERIENCE – General Manufacturing Technician

Associate's degree (A. A.) or equivalent from two-year College or technical school or equivalent combination of education and hands-on experience.  Acquired hands on experience working with automated production equipment, vibratory feeders, pneumatics, hydraulics, test equipment, measurement devices (calipers, meters, etc) and robotics. Understanding of basic principles of mechanical, pneumatic and hydraulic pressure, electricity, temperature and other physical properties. Able to read and understand complex engineering drawings. Prescribed industry accreditations/certificates will be considered in lieu of education and experience.  Completion of a state approved apprenticeship and papers preferred.

Note: The following additional job specific duties may be required of the position based upon the area the technician is specialized and assigned.

Machinist functions

  • Sets up and operates various equipment such as lathe, drill press, grinder, and other metalworking tools to make and repair parts.
  • Assists manufacturing in the installation/set-up, maintenance, repair and design input of the production grinding/press department which includes production wet surface grinders, Electrolytic cutoff, Electrolytic grinders, cannula grinders, tippers, punch presses plus numerous other support equipment included.
  • Assists with fabricating prototypes and models by interfacing with customers, process/product engineers, operators, outside services, etc. using prescribed production process or conventional machining equipment. This would include mold development.
  • Assists manufacturing technicians in the installation, removal and repair of injection molds in support of manufacturing production.
  • Repair and maintain precision grinding fixtures and chucks, oversee repair and maintenance of grinding machines.  Assist engineering with the design of improved fixtures and methods for grinding precision medical instrumentation.
  • Full access to a conventional machine shop, machinist must be able to perform most machining tasks in support of these responsibilities.

EDUCATION AND/OR EXPERIENCE - Machinist

Associates degree in engineering related discipline, four-year state-approved tool and die-maker apprenticeship, or 2-year technical trade school and  experience operating conventional machining equipment and/or training; or equivalent combination of education and experience.  Working introductory knowledge of SolidWorks or similar software. Knowledge of routine drafting practices and standards. Understanding of basic principles of mechanical pressure, electricity, temperature and other physical properties. Able to read and understand complex engineering drawings. Prescribed industry accreditations/certificates will be considered in lieu of education and experience.

Molding functions

  • Establishes injection molding processes on new product validations with the engineers. This includes but not limited to shear flow, pressure, temperature, safety parameters and mechanical settings used to develop the process.
  • Ability to utilize performance measurement tools such as viscocity curve, gate seal, cavity balance and Reynolds flow to debug and analyze performance of the molding press.
  • Installation, removal and rebuild of production molds which includes the use of manual lifts or overhead cranes to install and remove molds.
  • Diagnoses and replaces faulty mechanical, hydraulic and pneumatic components of machines and equipment.
  • Ability to analyze how a new resin will perform in producing a product.  Starting with initial process settings and then making necessary adjustments based upon the machine response to the quality of the product being produced.
  • Perform all preventive maintenance to the molding presses.

EDUCATION and/or EXPERIENCE - Molding

Associate's degree (A. A.) or equivalent from two-year college or technical school  or equivalent combination of education and hands-on experience plus 5 years experience in a manufacturing injection molding environment.  Prior Injection Molding setup experience, ability to operate various molding presses and familiar with cooling systems such as mokon units is required.  Ability to operate a standard lathe, milling machine and other tool-making equipment for fast turn-around of simple to moderately complex tooling and fixturing would be desired.

Electronic functions

  • Develops and repairs most electrical devices and test equipment within the facility.
  • Works with engineering on design and building of automated equipment including programming PLC controllers.
  • Installs power supply wiring and conduit for newly installed machines and equipment such as robots, conveyors, and programmable controllers.
  • Assembles experimental circuitry (breadboard) or complete prototype model.

EDUCATION and/or EXPERIENCE – Electronic Technician

Associate's degree (A. A.) or equivalent from two-year College or technical school or equivalent combination of education and hands-on experience.  Acquired hands on experience working with automation systems, PLC controllers, electrical motors, sensors, power supplies and their interface with equipment. PLC ladder logic programming and troubleshooting experience.

Apply today at Gage Personnel

  • Ephrata

    348 N. Reading Rd, Ephrata, PA

    Hours for applications are 8am-3pm Monday through Friday

    Call Katie at 717 336-5959 or send resume for immediate consideration to:

    Ephrataoffice@gagepersonnel.com

    We look forward to meeting with you!

 

Employment Type: 

Pay Rate: 

20-24

Location / Area: 

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