Assembler II, Sterile Single Use
1 month ago
POSITION SUMMARY
To assemble quality single sterile use endoscopes while adhering to prescribed standards.
MINIMUM KNOWLEDGE, EDUCATION AND SKILL REQUIREMENTS
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\tHigh school diploma, or equivalent experience.
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\t1-2 years of experience assembling miniature precision medical products preferred.
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\tProficient in all sub-assembly or basic endoscope or shaft assembly.
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\tMust possess ability to understand assembly drawings and written assembly procedures.
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\tAble to work in a class 8 cleanroom environment.
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\tAbility to meet takt time and quality standards.
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\tKnowledge of laser welding and electronics assembly (ESD grounding) preferred.
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\tMust have the ability to work with adhesives, solvents, microscopes, small hand and power tools, measurement devices and other related tools and equipment.
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\tMust be able to work well with coworkers.
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ESSENTIAL FUNCTIONS
PHYSICAL REQUIREMENTS
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\tMust be able to work overtime as needed.
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\tMust be punctual, able to sustain attendance guidelines, and work hours as assigned.
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\tGood manual dexterity and eye hand coordination.
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\tMust have the ability to consistently use hands for repetitive actions of simple and firm grasping and fine manipulation in order to assemble product.
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\tMust have the ability to regularly use his/her head and neck in flexing and rotating.
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\tMust have keen vision and the ability to pay close attention to details.
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\tMust be able to lift up to 10 pounds on a regular basis.
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\tMust have the ability to consistently perform detailed assembly work with a microscope for extended periods requiring physical stamina sufficient to sit for prolonged periods of time.
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\tMust have the ability to regularly bend, twist, push, pull, and reach above shoulder level.
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\tMust be able to regularly use manual or semi-automatic hand tools to torque, cut, polish, and clean parts.
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\tMust have the ability to be exposed to alcohol, solvents, epoxy, and adhesives.
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\tIt is not expected that this role will require driving as part of this job.
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MENTAL REQUIREMENTS
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\tAbility to learn new processes and procedures quickly.
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\tMust make decisions that affect coworkers and product quality.
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\tAbility to read English and understand SOP’s and manufacturing procedures.
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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.):
\t- 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.
\t - Semi-routine assembles of various intricate optical and mechanical components.
\t - Applies acquired job skills and company policies and procedures to complete assigned assembly tasks.
\t - Quantity of units produced should correspond to the time standards.
\t - Perform cleaning and inspection of various components using hand tools.
\t - Responsible for following prescribed assembly techniques and within assigned time standards to produce quality endoscope sub assemblies while meeting productivity guidelines.
\t - Actively participate in company sponsored training programs up to and including facilitating training as appropriate to role.
\t - Ability to cross train in other value stream assemblies as needed.
\t - Aware of practices and processes utilizing current management tools.
ENVIRONMENT, HEALTH AND SAFETY:
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\tMust 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.
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\tThe incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001.
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\tMust not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others.
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\tResponsible 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.
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\tOther specific safety responsibilities include proper use of personal and departmental safety equipment.
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\tSpecific safety hazards associated with this job include the handling of solvents, chemicals and adhesives.
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QUALITY
\t- 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
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\tMust be able to maintain productive working relationships with co-workers.
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\tMust treat fellow employees with respect.
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\tIndividual must daily communicate with coworkers to inform others of work status.
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\tMust have neat and legible handwriting to produce daily production records.
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\tIndividual should proactively communicate with management suggesting ways to improve products and processes.
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\tAbility to perform as a team member is a must.
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\tAbility to interact with different personalities throughout the organization.
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\tOTHER FUNCTIONS
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\tOTHER 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.)
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\tProduce and maintain production records.
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\tNotify proper personnel regarding manufacturing materials performance and stock levels.
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\tProperly complete all required production documents.
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\tClean and maintain personal and general work areas.
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