Operator I in Irvine

This is a non‑exempt position. The position is responsible for the production of high‑quality medical devices within a manufacturing cell. Working under close supervision, the incumbent may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. The employee will perform routine assignments according to specified or standardized procedures. Work is closely and continually reviewed, and the relevant job documentation for cell operations and functions is maintained accurate and up to date. The incumbent must be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form. A positive attitude in interactions with internal and external customers such as tours is maintained. Safety guidelines are followed and appropriate safety devices are utilized when performing all operations.

Responsibilities:

• Participate in continuous improvement/quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure inventory and quality documents are accurate, all parts are traceable, and quality issues can be addressed.
• Demonstrate 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 QMS, EMS, and other regulatory requirements.
• Read, comprehend, and follow written procedures; understand and follow verbal instructions.
• Utilize electronic data collection systems and computer software packages.
• Prioritise work by determining the sequencing and timing of different jobs based on precedence and importance.
• Handle and manoeuvre small components and parts.
• Make critical decisions and judgments with minimal supervision.

Qualifications:

• High school degree or equivalent required.

Dress Code and Safety:

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 dislodged are not allowed on clothing. To verify that a fabric can be worn: pull it tightly with 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 or scarves worn to accommodate customs must be covered with 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, 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 underneath. 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 allowed 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. Other scented personal use products are not allowed, except deodorant. Lotion must not be applied after hand washing. Cover any open or bleeding wound with a bandage. Do not wear anything that could be offensive.