Job Title: Operator
Location: Portland, OR
Shift & Schedule: 04:00 AM to 2:30 PM (MON to THU)
Position Summary: This position is responsible for the production of high-quality medical devices within a manufacturing cell. Under close supervision, the operator may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies.
Key Responsibilities:- Perform routine assembly, repair, and testing tasks according to specified and/or standardized procedures.
- Ensure relevant job documentation for cell operations is accurate and up to date.
- Clearly communicate ideas, problems, and solutions to all levels of manufacturing management, both in writing and verbally.
- Maintain a positive attitude when interacting with internal and external customers (e.g., tours).
- Follow safety guidelines and use appropriate safety devices during all operations.
- Participate in continuous improvement and quality initiatives to enhance production processes and achieve quality/profitability metrics.
- Maintain accurate records to ensure traveler and quality documents are traceable and complete.
- Demonstrate a basic understanding of Lean Manufacturing.
- Assist supervisors/managers in setting and monitoring individual and cell performance goals.
- Support divisional initiatives, Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Qualifications & Skills:- Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions.
- Proficiency with electronic data collection systems and computer software packages.
- Ability to prioritize work by determining sequencing and timing 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 diploma or equivalent preferred.
Required Dress Code (for interview and on-the-job):- Fabric & Garments:
- Clothing must be non-shedding, free of frayed hems, loose threads, tassels, fringe, glitter, sequins, or any items that could become dislodged.
- Test fabric: pull tightly with fingers if fibers dislodge, garment is not allowed.
- No sweaters, sweater vests, loose-knit, or fleece.
- All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.).
- Lab Coat/Gown Requirements:
- All clothing from the waist up must fit under the lab coat/gown.
- Turtle necks or high-necked clothing must not stick out above the coat neck.
- Sleeves must not extend beyond the cuffs.
- Headwear & Accessories:
- Caps, hats, scarves, or bandanas are not allowed under the bouffant.
- Head wraps/scarves for customs must be covered by the bouffant; tail ends must be fully covered by the lab coat. Must be tightly woven, clean, and laundered.
- Footwear:
- Shoes must be worn at all times in the production area.
- Stockings or socks required.
- Heel height d 2 inches, not pointed.
- No sandals, clogs, slippers, open-toe, open-heel, or shoes with straps/weave exposing toes.
- Changing shoes in production area (outside gowning room) is prohibited.
- Body Coverage:
- Torso, upper arms, and legs must be covered.
- No pants/skirts above the ankle, skirts with slits, short shirts (above navel), or sleeveless tops.
- Ankle-length skirts allowed only with full-length stockings, leggings, or pants underneath.
- Personal Grooming & Hygiene:
- No nail polish, acrylics, artificial nails, or similar coatings.
- No jewelry or body piercings that could pierce gloves or cannot be fully covered by gowning.
- No makeup. Lip balm in stick form allowed (apply outside production area, before hand washing).
- No scented products except deodorant. No lotion after hand washing.
- Cover open or bleeding wounds with a bandage.
- Prohibited Items:
- Loose-fitting clothing near machinery or soldering/brazing torches.
- Anything offensive in appearance.