Medical Device Assembler
Job Title: Operator I Location: Irvine, CA (Onsite) Contract Duration: Contract until 11/04/2026 Work Hours: 5:00 AM - 1:30 PM Cleanroom environment - Must be able to read and understand English Description: This is a non-exempt position. This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Performs routine assignments according to specified and standardized procedures. Work is closely and continually reviewed. Ensure that relevant job documentation for cell operations and functions is accurate and up to date. Be able to clearly communicate ideas, problems, and solutions to all levels of manufacturing management in both written and oral form. Maintain a positive attitude when interacting with internal and external customers such as tours. Follow safety guidelines and utilize appropriate safety devices when performing all operations. Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics. Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products. Demonstrates a basic understanding of Lean Manufacturing. Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions - Understanding of and ability to utilize electronic data collection systems and computer software packages. Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance. Ability to handle and maneuver small components and parts. Ability to make critical decisions and judgments with minimal supervision. A high school degree or equivalent is required. Required dress code for tour during interview and on-the job: Clothing must be non-shedding and free of frayed hems or loose threads. Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodges are not allowed on clothing. To verify a fabric can be worn: pull at the fabric tightly with your fingers, if fibers are dislodged, the garment may not be worn in the production area. Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn. All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.). All clothing, from the waist up, must fit under the lab coat/gown. Turtle necks or high-necked clothing shall not stick out above the neck of the lab coat/gown. Sleeves shall not stick out beyond the cuff of the lab coat/gown. Caps, hats, scarves, or bandanas shall not be worn under the bouffant. Head wraps/scarves worn to accommodate customs: Must be covered by the bouffant and the tail end of the scarf must be fully covered by the lab coat/gown. Must be of tightly woven fabric, be clean, and laundered. Loose-fitting clothing shall not be worn around machinery or soldering/brazing torches. Shoes must be worn at all times in the production area. Stockings or socks are required. The heel of a shoe must not be pointed or higher than 2 inches. Sandals, clogs, slippers, and open-toe, or open-heel shoes are not allowed. Shoes with straps or weave where toes can be seen are not allowed. Changing shoes in the production area, other than a gowning room, is not allowed. Torsos, upper arms, and legs must be covered. Pants (above the ankle), skirts (above the ankle), skirts with slits, short shirts (above the navel), and sleeveless tops are not allowed. Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn under them. Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed. Jewelry or body piercings that can pierce gloves or cannot be covered under gowning materials will not be permitted in the production area. Makeup shall not be worn. Lip balm in stick form is acceptable when applied outside of production areas and prior to hand washing. Scented personal use products shall not be worn, except deodorant. Lotions shall not be applied after hand washing. Cover any open or bleeding wound with a bandage. Don't wear anything that could be offensive. Maintain inventory and orders orthopedic medical supplies and/or durable medical equipment Assembling medical devices for a medical supply company in a laboratory clean room work environment Assembling medical devices in a laboratory clean room work environment Build complex medical devices under minimal direction and supervision Assembling medical kits according to PIC slips Completed in compliance with company quality system and medical device regulations Assemble medical products, performing a variety of tasks on a rotating basis Inspect, stock, and ship disposable medical supplies down the product line Assemble medical components, subassemblies, products or systems Utilizing hand-held/bench machinery to facilitate the assembly of medical products of a simple to complex nature Read and follow written work instructions Understanding of FDA and international regulatory requirements for medical device packaging validation Assemble and test medical devices and related products in accordance with documented work instructions and procedures Performing light assembly on medical devices according to client specifications Inspect assembles per Manufacturing Procedure or Assembly drawings Lead the start-up and ongoing operation of the Company's medical device package testing group Assemble and test medical device assemblies, final products, and accessories per the manufacturing documentation Assemble, bonds coats and process medical devices and related parts using microscopes and applicable tools Examine medical devices and related assemblies after molding operations to locate bubbles, nicks and/or excess epoxy Interpret applicable medical device regulations including 21 CFR Part 820, ISO standards, CDRH guidelines and medical device directives
