Assembler

Lancesoft; Irvine (CA); On-site; USD 25,000 - 39,000; Full time

Job summary

Lancesoft is seeking an on-site manufacturing assembler to assemble medical devices in a cleanroom environment, following strict GMP specifications. You will rotate across different operations, document data per GDP, and perform quality inspections to ensure product integrity.

Candidates must meet education requirements and be able to work onsite, with PPE and overtime as required. High school diploma or GED is acceptable, and strong attention to detail is essential.

Qualifications

• Ability to pass visual acuity test (20/20 corrected).
• Ability to read and comprehend manufacturing procedures.
• Ability to read, write, and understand English.
• Ability to communicate with leads and supervisors.

Responsibilities

• Assembles medical devices following GMP specifications.
• Available to rotate in different operations within manufacturing.
• Documents data or results per GDP; ensures accuracy.
• Performs in-process quality inspections and visual checks.
• Ensures proper PPE use and gowning for cleanroom entry.
• Will be on-site to perform essential functions and overtime as needed.

Skills

Visual acuity

Manufacturing procedures

English literacy

Communication with leads

Education

High school diploma

GED

Job description

Assembles and packs medical devices in a clean room/non-clean room environment following written and verbal specifications while performing the following duties.

Essential Duties and Responsibilities (List of Primary responsibilities of this role that account for 50% or more of the work. Incumbent may perform other duties as assigned.)

• Assembles medical devices following strict GMP s, specifications and procedures.
• Availability to rotate in different operations within the manufacturing process/training module assigned.
• Collaborates effectively within teams to foster strong relationships and minimize conflicts, promoting a harmonious work environment.
• When needed, may be requested to document data or results regarding manufacturing processes and assure that the information is accurate and according to GDP s.
• Able to determine quality of product at each stage of development and communicate issues and deviations regarding products and process immediately.
• Perform in-process quality inspections and checks including but not limited to visual inspection of devices, visual inspection of packaging materials, and air flow testing of devices.
• Able to document actions, data, or results regarding manufacturing processes and assures that the information is accurate and according to good documentation practices.
• Must be able to use sanitizer as part of the gowning process when entering the cleanroom.
• Perform cleaning and organization of manufacturing equipment, tools, and supplies.
• Demonstrates exceptional manual dexterity in performing intricate tasks, including assembly, or precision handling of tools and materials, ensuring high-quality and attention to detail.
• Able to exercise caution when handling product, materials, or tools to avoid damages, or scrap generation.
• Must be able to follow Safety requirements, instructions, and procedures.
• This position requires to be on-site to be able to perform the essential functions of the position.
• Must be able to use appropriate Personal Protective Equipment (PPE) such as appropriate gown, eye wear, face protection, shoe covering, and gloves.
• Must be able to work all scheduled hours including overtime.

Qualifications (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)

• Ability to pass visual acuity test (20/20 corrected vision) and pass Particulate Matter Certification
• Ability to read and comprehend manufacturing procedures.
• Ability to read, write, and understand English.
• Ability to communicate with leads and supervisors.

Education and/or Experience (Include the education and experience that is necessary to perform the job satisfactorily.)

• High School Diploma, GED, or equivalent.

Physical Demands & Working Environment (The physical demands & working environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.)

• The physical activity of this position Fingering.
• Picking, pinching, typing or otherwise working, primarily with fingers rather than with the whole hand as in handling.
• Talking.
• Expressing or exchanging ideas by means of the spoken word.
• Those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
• Hearing.
• Perceiving the nature of sounds at normal speaking levels with or without correction.
• Ability to receive detailed information through oral communication, and to make the discriminations in sound.
• Repetitive motion.
• Substantial movements (motions) of the wrists, hands, and/or fingers as related to administrative work.
• The physical requirements of this position Sedentary work.
• Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
• Sedentary work involves sitting most of the time.
• Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
• The visual acuity requirements include color, depth perception, and field vision.
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures;transcribing;viewing a computer terminal;extensive reading;visual inspection involving small defects, small parts, and/or operation of machines (including inspection);using measurement devices;and/or assembly or fabrication parts at distances close to the eyes.
• The conditions the worker will be subject to in this position None.
• The worker is not substantially exposed to adverse environmental conditions (such as in typical office or administrative work.)
• The worker is subject to noise.
• There is sufficient noise to cause the worker to shout in order to be heard above ambient noise level.
• The worker is subject to hazards.
• Includes a variety of physical conditions, such as proximity to moving mechanical parts, moving vehicles, electrical current, working on scaffolding and high places, exposure to high heat or exposure to chemicals.