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Assembler III, Sterile Single Use

3 months ago

Bellingham Massachusetts, Norfolk County, MA, United States KARL STORZ Endoscopy - America Full time

Shift Hours are Mon – Friday 6:30 – 3 pm for training and then a normal shift of 6:00 am – 2:30 pm.

POSITION SUMMARY

The purpose of this position is to apply substantial understanding of single sterile use endoscope assembly, subassemblies or miniature component assembly to perform a wide range of moderately difficult tasks.

MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS

  • High school diploma, or equivalent experience.
  • 2-4 years of experience assembling miniature precision medical products preferred.
  • Has substantial understanding of endoscope assembly or substantial understanding of shaft loading assembly or final shaft to handle assembly tasks.
  • Must possess ability to understand assembly drawings and written assembly procedures.
  • Able to work in a class 8 cleanroom environment.
  • Ability to meet takt time and quality standards.
  • Knowledge of laser welding and electronics assembly (ESD grounding) and inspection required.
  • Must have the ability to work with adhesives, solvents, microscopes, small hand and power tools, measurement devices and other related tools and equipment.
  • Must be able to work well with coworkers.

PHYSICAL REQUIREMENTS

  • Must be able to sit and perform detailed assembly work with a microscope for extended periods.
  • May be required to lift as much as 20 lbs from the floor to tabletop level.
  • Requires minimal walking
  • Infrequent bending, reaching of items up to 10 pounds.
  • Must be able to frequently bend, twist, push, pull and on a moderate basis reach over shoulder level to pick up small parts no more than 5 pounds.
  • Must be able to work with small hand and power tools using frequent arm and wrist movements that require fine hand and motor skills. Frequent pinch grip required.
  • Must be able to use Personal Protective Equipment when necessary: gloves, finger cots, and safety glasses.
  • Must be able to frequently use microscope, small hand and power tools, measurement devices and other related tools and equipment. Must be able to regularly use his or her head and neck in flexing and rotating.
  • It is not expected that this role will require driving as part of this job.
  • Must be able to work with alcohol, solvents, lubricants, epoxy, and adhesives.
  • Must be able to work overtime as needed.
  • Must be punctual, able to sustain attendance guidelines, and work hours as assigned.
  • Excellent manual dexterity and keen vision with the ability to pay close attention to details.

MENTAL REQUIREMENTS

  • Ability to learn new processes and procedures quickly.
  • Must make decisions that affect coworkers and product quality.
  • Ability to read English and understand SOP’s and manufacturing procedures.

DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

  • All employees are expected to be knowledgeable about and follow the Company’s Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment.
  • Moderately difficult assembles of various intricate optical and mechanical components.
  • Applies substantial understanding of endoscope assembly, subassemblies, or miniature component assembly to perform a wide range of tasks.
  • Responsible for following prescribed assembly techniques and within assigned time standards to produce quality endoscope sub assemblies while meeting productivity guidelines.
  • Quantity of units produced should correspond to the time standards.
  • Perform cleaning and inspection of various components using hand tools.
  • Actively participate in company sponsored training programs up to and including facilitating training as appropriate to role.
  • Ability to cross train in other value stream assemblies as needed.
  • Aware of practices and processes utilizing current management tools.

ENVIRONMENT, HEALTH AND SAFETY

  • Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company’s environmental and safety policies and procedures. Must be willing to report actual and potential environmental and safety violations to appropriate supervisory and/or management personnel.
  • The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
  • Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
  • Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties.
  • Other specific safety responsibilities include proper use of personal and departmental safety equipment.
  • Specific safety hazards associated with this job include the handling of solvents, chemicals and adhesives.

QUALITY

  • The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, ISO 13485 and ISO 9001 (current revisions).

INTERPERSONAL AND COMMUNICATION SKILLS

  • Must be able to maintain productive working relationships with co-workers.
  • Must treat fellow employees with respect.
  • Individual must daily communicate with coworkers to inform others of work status.
  • Must have neat and legible handwriting to produce daily production records.
  • Individual should proactively communicate with management suggesting ways to improve products and processes.
  • Ability to perform as a team member is a must.
  • Ability to interact with different personalities throughout the organization.

OTHER DUTIES AND RESPONSIBILITIES (Other duties consistent with the general nature and focus of the position and/or the goals and objectives of the department may be assigned.)

  • Produce and maintain production records.
  • Notify proper personnel regarding manufacturing materials performance and stock levels.
  • Properly complete all required production documents.
  • Clean and maintain personal and general work areas.

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