Medical Device Assembler

Medical Device Assembler

Location: Pleasanton, CA Shift Timings: 5 AM - 01:30 PM Pay Rate: 21.50/hr

Job Summary

This position is responsible for the production of high-quality medical devices within a manufacturing cell. Working under close supervision, the employee may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. The role involves routine assignments following specified and/or standardized procedures, with work being closely and continually reviewed.

Essential Duties and Responsibilities

• Ensure that relevant job documentation for cell operations and functions is accurate and up to date.
• 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 during tours.
• Follow safety guidelines and utilize appropriate safety devices when performing all operations.
• Participate in continuous improvement/quality initiatives to enhance production processes and achieve quality and profitability metrics.
• Maintain accurate records to ensure traveler and quality documents are precise, all parts are traceable, and quality issues can be addressed.
• Demonstrate a basic understanding of Lean Manufacturing.
• Work with the Manufacturing Supervisor/Manager to set and monitor individual goals and cell performance metrics that continuously seek to improve the quality of operations.
• Support all Divisional initiatives as identified by divisional management in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Qualifications and Requirements

• Education: Required for this position.
• 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 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.
• High school degree or equivalent preferred.

Dress Code and Grooming Requirements

• Clothing must be non-shedding and free of frayed hems or loose threads.
• Tassels, fringes, glitter, sequins (sewn or glued on), or any other items that could become dislodged are not allowed.
• Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn.
• 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. Turtlenecks or high-necked clothing must 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 for customs must be covered with the bouffant, be made of tightly woven fabric, and 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 in 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 allowed in the production area.
• Makeup shall not be worn, except for lip balm in stick form, which is allowed when applied outside of production areas and before 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.
• Do not wear anything that could be offensive.